Budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg orally taken once daily in the morning for up to 8 weeks. Repeated 8 week courses of budesonide capsules (enteric coated) can be given for recurring episodes of active disease. Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms a...
NDC:68151-4374-0 in a PACKAGE of 1 CAPSULES
www.fda.gov/medwatchBudesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.
Budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg orally taken once daily in the morning for up to 8 weeks. Repeated 8 week courses of budesonide capsules (enteric coated) can be given for recurring episodes of active disease.
Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), budesonide capsules (enteric coated) 6 mg orally is recommended once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with budesonide capsules (enteric coated) 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.
Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to budesonide capsules (enteric coated) with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating budesonide capsule (enteric coated) treatment.
If concomitant administration with ketoconazole, or any other CYP3A4 inhibitor, is indicated, patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Grapefruit juice, which is known to inhibit CYP3A4, should also be avoided when taking budesonide capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered [ ]. see and Drug Interactions (7) Clinical Pharmacology (12.3)
Budesonide capsules (enteric coated) 3 mg have a red opaque cap and red opaque body, hard shell gelatin capsule filled with white to off-white enteric-coated pellets with no markings. The capsules are axially printed with over in black ink on both the cap and body. MYLAN 7155
Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Anaphylactic reactions have occurred [ ]. see Adverse Reactions (6.2)
When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic glucocorticosteroid is recommended. Since budesonide capsules (enteric coated) are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
Care is needed in patients who are transferred from glucocorticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as budesonide capsules (enteric coated), since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously.
Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure.
How the dose, route and duration of glucocorticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior glucocorticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See prescribing information for VZIG and IG.) If chicken pox develops, treatment with antiviral agents may be considered.
Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections.
Replacement of systemic glucocorticosteroids with budesonide capsules (enteric coated) may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.
Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis [ ]. see Use in Specific Populations (8.6)
Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.
Systemic glucocorticosteroid use may result in the following:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of budesonide capsules (enteric coated) was evaluated in 651 patients in five short-term, active disease state studies. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were greater than or equal to 65 years of age. Five hundred and twenty patients were treated with budesonide capsules (enteric coated) 9 mg (total daily dose). The most common adverse reactions reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse reactions was substantially reduced with budesonide capsules (enteric coated) compared with prednisolone at therapeutically equivalent doses. Adverse reactions occurring in greater than or equal to 5% of the patients are listed in Table 1:
Budesonide Capsules (Enteric Coated) 9 mg n = 520 | Placebo n = 107 | Prednisolone 40 mg n = 145 | Comparator* n = 88 | |
Adverse Reaction | Number (%) | Number (%) | Number (%) | Number (%) |
Headache | 107(21) | 19(18) | 31(21) | 11(13) |
Respiratory Infection | 55(11) | 7(7) | 20(14) | 5(6) |
Nausea | 57(11) | 10(9) | 18(12) | 7(8) |
Back Pain | 36(7) | 10(9) | 17(12) | 5(6) |
Dyspepsia | 31(6) | 4(4) | 17(12) | 3(3) |
Dizziness | 38(7) | 5(5) | 18(12) | 5(6) |
Abdominal Pain | 32(6) | 18(17) | 6(4) | 10(11) |
Flatulence | 30(6) | 6(6) | 12(8) | 5(6) |
Vomiting | 29(6) | 6(6) | 6(4) | 6(7) |
Fatigue | 25(5) | 8(7) | 11(8) | 0(0) |
Pain | 24(5) | 8(7) | 17(12) | 2(2) |
* This drug is not approved for the treatment of Crohn’s disease in the United States.
The safety of budesonide capsules (enteric coated) was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with budesonide capsules (enteric coated) 6 mg. A total of 8% of budesonide capsule (enteric coated) patients discontinued treatment due to adverse reactions compared with 10% in the placebo group. The adverse reaction profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with budesonide capsules (enteric coated) 9 mg in active Crohn’s disease.
In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% of the 6 mg budesonide capsule (enteric coated) patients and are not listed in (Table 1) or by body system below: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%).
Adverse reactions, occurring in patients treated with budesonide capsules (enteric coated) 9 mg (total daily dose) in short-term active disease state studies and/or budesonide capsules (enteric coated) 6 mg (total daily dose) long-term, with an incidence less than 5% and greater than placebo are listed below by system organ class:
Table 2 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials.
Budesonide Capsules (Enteric Coated) 9 mg n = 427 | Placebo n = 107 | Prednisolone Taper 40 mg
n = 145 | |
Signs/Symptom | Number (%) | Number (%) | Number (%) |
Acne | 63(15) | 14(13) | 33(23) * |
Bruising Easily | 63(15) | 12(11) | 13(9) |
Moon Face | 46(11) | 4(4) | 53(37) |
Swollen Ankles | 32(7) | 6(6) | 13(9) |
Hirsutism † | 22(5) | 2(2) | 5(3) |
Buffalo Hump | 6(1) | 2(2) | 5(3) |
Skin Striae | 4(1) | 2(2) | 0(0) |
* Statistically significantly different from budesonide capsules (enteric coated) 9 mg.
† Adverse reaction dictionary included term hair growth increased, local and hair growth increased, general.
Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials.
Budesonide Capsules (Enteric Coated) 3 mg n = 88 | Budesonide Capsules (Enteric Coated) 6 mg n = 145 | Placebo n = 143 | |
Signs/Symptom | Number (%) | Number (%) | Number (%) |
Bruising Easily | 4(5) | 15(10) | 5(4) |
Acne | 4(5) | 14(10) | 3(2) |
Moon Face | 3 (3) | 6(4) | 0 |
Hirsutism | 2 (2) | 5(3) | 1(1) |
Swollen Ankles | 2 (2) | 3(2) | 3(2) |
Buffalo Hump | 1 (1) | 1 (1) | 0 |
Skin Striae | 2 (2) | 0 | 0 |
The incidence of signs/symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials.
A randomized, open, parallel-group multicenter safety study specifically compared the effect of budesonide capsules (enteric coated) (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with budesonide capsules (enteric coated) than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of symptoms associated with hypercorticism was significantly higher with prednisolone treatment.
The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to budesonide capsules (enteric coated), were reported in greater than or equal to 1% of patients: hypokalemia, leukocytosis, anemia, hematuria, pyuria, erythrocyte sedimentation rate increased, alkaline phosphatase increased, atypical neutrophils, C-reactive protein increased, and adrenal insufficiency.
The following adverse reactions have been reported during post-approval use of budesonide capsules (enteric coated). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Concomitant oral administration of ketoconazole (a known inhibitor of CYP3A4 activity in the liver and in the intestinal mucosa) caused an 8-fold increase of the systemic exposure to oral budesonide. If treatment with inhibitors of CYP3A4 activity (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, etc.) is indicated, reduction of the budesonide dose should be considered. After extensive intake of grapefruit juice (which inhibits CYP3A4 activity predominantly in the intestinal mucosa), the systemic exposure for oral budesonide increased about two times. Ingestion of grapefruit or grapefruit juice should be avoided in connection with budesonide administration [ ]. see Clinical Pharmacology (12.3)
Budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on a body surface area basis).
There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.
The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum . Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies. Breast milk obtained over eight hours post-dose revealed that the maximum budesonide concentration for the 400 and 800 mcg total daily doses was 0.39 and 0.78 nmol/L, respectively, and occurred within 45 minutes after inhalation. The estimated oral daily dose of budesonide from breast milk to the infant is approximately 0.007 and 0.014 mcg/kg per day for the two dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Budesonide plasma concentrations obtained from five infants at about 90 minutes after breast feeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (less than 0.02 nmol/L in four infants and less than 0.04 nmol/L in one infant). 1
The recommended daily dose of budesonide capsules (enteric coated) is higher (up to 9 mg daily) compared with inhaled budesonide (up to 800 mg daily) given to mothers in the above study. The maximum budesonide plasma concentration following a 9 mg daily dose (in both single- and repeated-dose pharmacokinetic studies) of oral budesonide is approximately 5 to 10 nmol/L which is up to 10 times higher than the 1 to 2 nmol/L for a 800 mg daily dose of inhaled budesonide at steady state in the above inhalation study.
Since there are no data from controlled trials on the use of budesonide capsules (enteric coated) by nursing mothers or their infants, and because of the potential for serious adverse reactions in nursing infants from budesonide capsules (enteric coated), a decision should be made whether to discontinue nursing or to discontinue budesonide capsules (enteric coated), taking into account the clinical importance of budesonide capsules (enteric coated) to the mother.
Budesonide is secreted in human milk. Data from budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. Assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of budesonide capsules (enteric coated), budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.
Safety and effectiveness in pediatric patients have not been established. Systemic and inhaled corticosteroids, including budesonide capsules (enteric coated), may cause a reduction of growth velocity in pediatric patients.
Clinical studies of budesonide capsules (enteric coated) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Reducing the dose of budesonide capsules (enteric coated) should be considered in these patients [ ]. see Warnings and Precautions (5.4)
Reports of acute toxicity and/or death following overdosage of glucocorticosteroids are rare. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
If glucocorticosteroids are used at excessive doses for prolonged periods, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may occur. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily.
Single oral doses of 200 and 400 mg/kg were lethal in female and male mice, respectively. The signs of acute toxicity were decreased motor activity, piloerection and generalized edema.
Budesonide the active ingredient of budesonide capsules (enteric coated), is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C H O and its molecular weight is 430.5. Its structural formula is: 25 34 6
Budesonide, USP is a white to almost white crystalline powder that is freely soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10 ionic strength 0.01. 3
Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, dimethicone, ethylcellulose, FD&C Red No. 40 Aluminum Lake, gelatin, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.
The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, Propylene Glycol and shellac glaze.
Budesonide has a high topical glucocorticosteroid (GCS) activity and a substantial first pass elimination. The formulation contains granules which are coated to protect dissolution in gastric juice, but which dissolve at pH greater than 5.5, i.e., normally when the granules reach the duodenum. Thereafter, a matrix of ethylcellulose with budesonide controls the release of the drug into the intestinal lumen in a time-dependent manner.
Budesonide has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to GCS receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.
Treatment with systemically active GCS is associated with a suppression of endogenous cortisol concentrations and an impairment of the hypothalamus-pituitary-adrenal (HPA) axis function. Markers, indirect and direct, of this are cortisol levels in plasma or urine and response to ACTH stimulation.
Plasma cortisol suppression was compared following 5 days’ administration of budesonide capsules (enteric coated) and prednisolone in a crossover study in healthy volunteers. The mean decrease in the integrated 0 to 24 hour plasma cortisol concentration was greater (78%) with prednisolone 20 mg per day compared to 45% with budesonide capsules (enteric coated) 9 mg per day.
The absorption of budesonide capsules (enteric coated) seems to be complete, although C and T are variable. Time to peak concentration varies in individual patients between 30 and 600 minutes. Following oral administration of 9 mg of budesonide in healthy subjects, a peak plasma concentration of approximately 5 nmol/L is observed and the area under the plasma concentration time curve is approximately 30 nmol•hr/L. The systemic availability after a single dose is higher in patients with Crohn's disease compared to healthy volunteers, (21% vs 9%) but approaches that in healthy volunteers after repeated dosing. max max
The mean volume of distribution (V ) of budesonide varies between 2.2 and 3.9 L/kg in healthy subjects and in patients. Plasma protein binding is estimated to be 85 to 90% in the concentration range 1 to 230 nmol/L, independent of gender. The erythrocyte/plasma partition ratio at clinically relevant concentrations is about 0.8. ss
Following absorption, budesonide is subject to high first pass metabolism (80% to 90%). experiments in human liver microsomes demonstrate that budesonide is rapidly and extensively biotransformed, mainly by CYP3A4, to its two major metabolites, 6β-hydroxy budesonide and 16α-hydroxy prednisolone. The glucocorticoid activity of these metabolites is negligible (less than 1/100) in relation to that of the parent compound. In vitro
investigations with intravenous doses in healthy subjects are in agreement with the findings and demonstrate that budesonide has a high plasma clearance, 0.9 to 1.8 L/min. Similarly, high plasma clearance values have been shown in patients with Crohn’s disease. These high plasma clearance values approach the estimated liver blood flow, and, accordingly, suggest that budesonide is a high hepatic clearance drug. In vivo in vitro
The plasma elimination half-life, t , after administration of intravenous doses ranges between 2 and 3.6 hours, and does not differ between healthy adults and patients with Crohn’s disease. 1/2
Budesonide is excreted in urine and feces in the form of metabolites. After oral as well as intravenous administration of micronized [ H]-budesonide, approximately 60% of the recovered radioactivity is found in urine. The major metabolites, including 6β-hydroxy budesonide and 16α-hydroxy prednisolone, are mainly renally excreted, intact or in conjugated forms. No unchanged budesonide is detected in urine. 3
No significant pharmacokinetic differences have been identified due to gender.
In patients with liver cirrhosis, systemic availability of orally administered budesonide correlates with disease severity and is, on average, 2.5-fold higher compared with healthy controls. Patients with mild liver disease are minimally affected. Patients with severe liver dysfunction were not studied. Absorption parameters are not altered, and for the intravenous dose, no significant differences in CL or V are observed. ss
The pharmacokinetics of budesonide in patients with renal impairment has not been studied. Intact budesonide is not renally excreted, but metabolites are to a large extent, and might therefore reach higher levels in patients with impaired renal function. However, these metabolites have negligible corticosteroid activity as compared with budesonide (less than 1/100).
Budesonide is metabolized via CYP3A4. Potent inhibitors of CYP3A4 can increase the plasma levels of budesonide several-fold. Co-administration of ketoconazole results in an 8-fold increase in AUC of budesonide, compared to budesonide alone. Grapefruit juice, an inhibitor of gut mucosal CYP3A, approximately doubles the systemic exposure of oral budesonide. Conversely, induction of CYP3A4 can result in the lowering of budesonide plasma levels.
Oral contraceptives containing ethinyl estradiol, which are also metabolized by CYP3A4, do not affect the pharmacokinetics of budesonide. Budesonide does not affect the plasma levels of oral contraceptives (i.e., ethinyl estradiol) [ ]. see Drug Interactions (7)
Since the dissolution of the coating of budesonide capsules (enteric coated) is pH dependent (dissolves at pH greater than 5.5), the release properties and uptake of the compound may be altered after treatment with drugs that change the gastrointestinal pH. However, the gastric acid inhibitory drug omeprazole, 20 mg once daily does not affect the absorption or pharmacokinetics of budesonide capsules (enteric coated). When an uncoated oral formulation of budesonide is co-administered with a daily dose of cimetidine 1 g, a slight increase in the budesonide peak plasma concentration and rate of absorption occurs, resulting in significant cortisol suppression.
A mean delay in time to peak concentration of 2.5 hours is observed with the intake of a high-fat meal, with no significant differences in AUC.
Carcinogenicity studies with budesonide were conducted in rats and mice. In a 2-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In addition, there were increased incidences of primary hepatocellular tumors in male rats at 25 mcg/kg (approximately 0.023 times the maximum recommended human dose on a body surface area basis) and above. No tumorigenicity was seen in female rats at oral doses up to 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In an additional 2-year study in male Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). However, it caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) showed similar findings. In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately 0.1 times the maximum recommended human dose on a body surface area basis).
Budesonide was not genotoxic in the Ames test, the mouse lymphoma cell forward gene mutation (TK ) test, the human lymphocyte chromosome aberration test, the sex-linked recessive lethality test, the rat hepatocyte UDS test and the mouse micronucleus test. +/- Drosophila melanogaster
In rats, budesonide had no effect on fertility at subcutaneous doses up to 80 mcg/kg (approximately 0.07 times the maximum recommended human dose on a body surface area basis). However, it caused a decrease in prenatal viability and viability in pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg (approximately 0.02 times the maximum recommended human dose on a body surface area basis) and above. No such effects were noted at 5 mcg/kg (approximately 0.005 times the maximum recommended human dose on a body surface area basis).
The safety and efficacy of budesonide capsules (enteric coated)were evaluated in 994 patients with mild to moderate active Crohn’s disease of the ileum and/or ascending colon in five randomized and double-blind studies. The study patients ranged in age from 17 to 85 (mean 35), 40% were male and 97% were white. Of the 651 patients treated with budesonide capsules (enteric coated), 17 (2.6%) were greater than or equal to 65 years of age and none were greater than 74 years of age. The Crohn’s Disease Activity Index (CDAI) was the main clinical assessment used for determining efficacy in these five studies. The CDAI is a validated index based on subjective aspects rated by the patient (frequency of liquid or very soft stools, abdominal pain rating and general well-being) and objective observations (number of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit). Clinical improvement, defined as a CDAI score of less than or equal to 150 assessed after 8 weeks of treatment, was the primary efficacy variable in these five comparative efficacy studies of budesonide capsules (enteric coated). Safety assessments in these studies included monitoring of adverse reactions. A checklist of potential symptoms of hypercorticism was used.
One study (Study 1) compared the safety and efficacy of budesonide capsules (enteric coated) 9 mg daily in the morning to a comparator. At baseline, the median CDAI was 272. Budesonide capsules (enteric coated) 9 mg daily resulted in a significantly higher clinical improvement rate at Week 8 than the comparator. See Table 4.
Clinical | Budesonide Capsules (Enteric Coated) | Comparator* | Placebo | Prednisolone | |
Study | 9 mg Daily | 4.5 mg Twice Daily | |||
1 | 62/91 (69%) | 37/83 (45%) | |||
2 | 31/61 (51%) | 13/64 (20%) | |||
3 | 38/79 (48%) | 41/78 (53%) | 13/40 (33%) | ||
4 | 35/58 (60%) | 25/60 (42%) | 35/58 (60%) | ||
5 | 45/86 (52%) | 56/85 (65%) | |||
* This drug is not approved for the treatment of Crohn’s disease in the United States.
Two placebo-controlled clinical trials (Studies 2 and 3) were conducted. Study 2 involved 258 patients and tested the effects of graded doses of budesonide capsules (enteric coated) (1.5 mg twice daily, 4.5 mg twice daily, or 7.5 mg twice daily) versus placebo. At baseline, the median CDAI was 290. The 3 mg per day dose level (data not shown) could not be differentiated from placebo. The 9 mg per day arm was statistically different from placebo (Table 4), while no additional benefit was seen when the daily budesonide capsule (enteric coated) dose was increased to 15 mg per day (data not shown). In Study 3, the median CDAI at baseline was 263. Neither 9 mg daily nor 4.5 mg twice daily budesonide capsule (enteric coated) dose levels was statistically different from placebo (Table 4).
Two clinical trials (Studies 4 and 5) compared budesonide capsules (enteric coated) with oral prednisolone (initial dose 40 mg per day). At baseline, the median CDAI was 277. Equal clinical improvement rates (60%) were seen in the budesonide capsules (enteric coated) 9 mg daily and the prednisolone groups in Study 4. In Study 5, 13% fewer patients in the budesonide capsules (enteric coated) group experienced clinical improvement than in the prednisolone group (no statistical difference) (Table 4).
The proportion of patients with normal plasma cortisol values (greater than 150 nmol/L) was significantly higher in the budesonide capsule (enteric coated) groups in both trials (60% to 66%) than in the prednisolone groups (26% to 28%) at Week 8.
The efficacy and safety of budesonide capsules (enteric coated) for maintenance of clinical remission were evaluated in four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with 3 mg or 6 mg budesonide capsules (enteric coated) or placebo. Patients ranged in age from 18 to 73 (mean 37) years. Sixty percent of the patients were female and 99% were Caucasian. The mean CDAI at entry was 96. Among the four clinical trials, approximately 75% of the patients enrolled had exclusively ileal disease. Colonoscopy was not performed following treatment. Budesonide capsules (enteric coated) 6 mg per day prolonged the time to relapse, defined as an increase in CDAI of at least 60 units to a total score greater than 150 or withdrawal due to disease deterioration. The median time to relapse in the pooled population of the four studies was 154 days for patients taking placebo, and 268 days for patients taking budesonide capsules (enteric coated) 6 mg per day. Budesonide capsules (enteric coated) 6 mg per day reduced the proportion of patients with loss of symptom control relative to placebo in the pooled population for the four studies at 3 months (28% vs. 45% for placebo).
NDC:68151-4374-0 in a PACKAGE of 1 CAPSULES
“See FDA-Approved Patient Labeling ( )” Patient Information
Patients being treated with budesonide capsules (enteric coated) should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For proper use of budesonide capsules (enteric coated) and to attain maximum improvement, the patient should read and follow the accompanying FDA-Approved Patient Labeling.
Patients should be advised that budesonide capsules (enteric coated) may cause systemic glucocorticosteroid effects of hypercorticism and adrenal suppression. Patients should taper slowly from systemic glucocorticosteroids if transferring to budesonide capsules (enteric coated) [ ]. see and Warnings and Precautions (5.1) (5.2)
Patients who are on immunosuppressant doses of glucocorticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections [ ]. see Warnings and Precautions (5.3)
Budesonide capsules (enteric coated) should be swallowed whole and NOT CHEWED OR BROKEN. Patients should be advised to avoid the consumption of grapefruit juice for the duration of their budesonide capsules (enteric coated) therapy.
PATIENT INFORMATION LEAFLET BUDESONIDE CAPSULES (enteric coated) (bue des' oh nide) 3 mg
Read the Patient Information that comes with budesonide capsules (enteric coated) before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What are budesonide capsules (enteric coated)?
Budesonide capsules (enteric coated) are a prescription glucocorticosteroid medicine used in people with mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):
It is not known if budesonide capsules (enteric coated) are safe and effective in children.
Who should not take budesonide capsules (enteric coated)?
Do not take budesonide capsules (enteric coated)if:
What should I tell my healthcare provider before taking budesonide capsules (enteric coated)?
: Before you take budesonide capsules (enteric coated) tell your healthcare provider if you
including prescription and non-prescription medicines, vitamins, and herbal supplements. Budesonide capsules (enteric coated) and other medicines may affect each other causing side effects. Tell your healthcare provider about all the medicines you take,
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.
How should I take budesonide capsules (enteric coated)?
What should I avoid while taking budesonide capsules (enteric coated)?
What are the possible side effects of budesonide capsules (enteric coated)?
The most common side effects of budesonide capsules (enteric coated) include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of budesonide capsules (enteric coated). For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How should I store budesonide capsules (enteric coated)?
Keep budesonide capsules (enteric coated)and all medicines out of reach from children.
General information about budesonide capsules (enteric coated).
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use budesonide capsules (enteric coated) for a condition for which it was not prescribed. Do not give budesonide capsules (enteric coated) to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about budesonide capsules (enteric coated). If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about budesonide capsules (enteric coated) that is written for health professionals.
For more information call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in budesonide capsules (enteric coated)?
Active ingredient: budesonide, USP
Inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, dimethicone, ethylcellulose, FD&C Red No. 40 Aluminum Lake, gelatin, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.
The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, Propylene Glycol and shellac glaze.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Morgantown, WV 26505 U.S.A.
Mylan Pharmaceuticals Inc.
REVISED FEBRUARY 2014 BUDE:R2ppt
| Class | Version | Type | Effective |
|---|---|---|---|
| BUDESONIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7816cdf6-b925-4282-bedd-11ae25d518a1 | Product name | 1 | 20250116 |
| d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d | Product name | 2 | 20240424 |
| 9ab9f611-cedd-47ea-a83c-0489c8c04fc6 | Product name | 1 | 20231006 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| a03aea00-1d8b-bfad-a82e-f52f68676f63 | Product name | 2 | 20221216 |
| 54a29484-7dde-4771-9547-005149321621 | Product name | 1 | 20220720 |
| 793b53dd-c0ea-da17-9ac0-fb5c4a6e0743 | Product name | 5 | 20211018 |
| 218c043e-94e5-4e66-a363-d0d446485bc6 | Product name | 2 | 20210512 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7 | Product name | 9 | 20210127 |
| da63bc8c-2e89-4044-89d6-1facbff5474e | Product name | 1 | 20200121 |
| 899766bc-33ce-8154-910d-12cb0889fb56 | Product name | 2 | 20150106 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-4374-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cb47-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997 budesonide capsules (enteric coated) budesonide capsules (enteric coated) BUDESONIDE capsules (enteric coated), for oral use |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-4374-0 | Budesonide | 1 in 1 PACKAGE | CAPSULE | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-4374 | BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140820_7633c9b3-dfb5-446f-a260-e44b6e48afa2.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7155-01 | EA - Each | 0378-7155 | 4f6e5f1c-0fab-44ed-bc20-0b33d4275987 | 1 | 2012-07-24 |
| 0378-7155-05 | EA - Each | 0378-7155 | 83afd047-ea72-4088-b4fb-d816ee8ec1f8 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BUDESONIDE | ACTIVE INGREDIENT | Q3OKS62Q6X | 2 | |
| BUDESONIDE | ACTIVE MOIETY | Q3OKS62Q6X | 2 | |
| ACETYLTRIBUTYL CITRATE | INACTIVE INGREDIENT | 0ZBX0N59RZ | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68151-4374 | 68151-4374-0 |
| 0378-7155 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / TOPICAL | 0.2 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / OPHTHALMIC | 6 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 34 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRALESIONAL | ADJ PH | ||
| ACETYLTRIBUTYL CITRATE | ACETYLTRIBUTYL CITRATE | 0ZBX0N59RZ | CAPSULE, EXTENDED RELEASE / ORAL | 23 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 570 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GRANULE, FOR SUSPENSION / ORAL | 240 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | SUSPENSION / ORAL | 1306 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBCUTANEOUS | 1 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / ORAL | 233 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / RECTAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, COATED PELLETS / ORAL | 29 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, FILM COATED / ORAL | 83 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERINEURAL | ADJ PH | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCONJUNCTIVAL | ADJ PH | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090410-001 | BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 |
| Application-product | TE code |
|---|---|
| A090410-001 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090410-001 | BUDESONIDE | 3MG | CAPSULE / ORAL | AB | 2011-05-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090410-001 | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2011-05-16 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090410-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090410-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090410-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090410-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090410-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090410-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090410-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090410-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090410-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090410-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090410-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090410-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090410-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090410-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090410-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090410-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090410-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090410-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090410-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090410-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090410-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090410-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090410-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090410-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090410-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090410-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090410-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090410-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090410-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090410-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090410-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090410-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090410-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090410-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090410-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090410-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090410-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090410-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090410-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090410-001 | AB | 1 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e0daaa9-b926-4033-93c4-47fefd919ed3 | 7633c9b3-dfb5-446f-a260-e44b6e48afa2 | 2014-03-05 | Warnings, Adverse reactions | 4e0daaa9-b926-4033-93c4-47fefd919ed3 7633c9b3-dfb5-446f-a260-e44b6e48afa2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.