Calcium Acetate Capsules, 667 mg are hard gelatin capsules with white opaque body imprinted with “590” and light-blue opaque cap imprinted with “AMNEAL” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. They are available as follows: Bottles of 200: NDC 42291-189-20 STORAGE: Store at 20° to 25°C (68° to 77°F); excur...
www.fda.gov/medwatchCalcium acetate, USP is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
The recommended initial dose of calcium acetate, USP for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
Capsule: 667 mg calcium acetate, USP per capsule.
Patients with hypercalcemia.
Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate.
An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia.
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3-month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg 2/dL 2.
Hypercalcemia may aggravate digitalis toxicity.
Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]
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.
In clinical studies, calcium acetate has been generally well tolerated.
Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
|
Table 1: Adverse Reactions in Patients with End-Stage Renal Disease
Undergoing Hemodialysis | ||||
| Preferred Term |
Total advers
reactions reported for calcium acetate n=167 n (%) |
3-mo, open-label
study of calcium acetate n=98 n (%) |
Double blind, placebo-controlled,
cross-over study of liquid calcium acetate n=69 | |
|
Calcium acetate
n (%) |
Placebo
n (%) | |||
| Nausea | 6 (3.6) | 6 (6.1) | 0 (0) | 0 (0) |
| Vomiting | 4 (2.4) | 4 (4.1) | 0 (0) | 0 (0) |
| Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate-induced hypercalcemia. Isolated cases of pruritus have been reported, which may represent allergic reactions.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.
The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between calcium acetate or calcium acetate capsules and most concomitant drugs. When administering an oral medication with calcium acetate capsules where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate capsules or calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate.
In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.
Pregnancy Category C
Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ]. Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
The effects of calcium acetate on labor and delivery are unknown.
Calcium acetate capsules contain calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between 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.
To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].
Calcium acetate, USP acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4H 6CaO 4, and its molecular weight is 158.17. Its structural formula is:
Each capsule has a light-blue cap imprinted with “AMNEAL” and white body imprinted with “590” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Each capsule also contains the following inactive ingredients: FD&C Blue #1, FD&C Red #3, gelatin, magnesium stearate, polyethylene glycol and titanium dioxide. In addition to the inactive ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains D&C Yellow #10, FD&C Blue #2, FD&C Red #40, iron oxide black and shellac. Opacode (Black) may also contain ethanol, methanol, n-butyl alcohol and propylene glycol.
Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.
Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1-week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received calcium acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented.
|
Table 2: Average Serum Phosphorous and Calcium Levels at
Pre-Study, Interim, and Study Completion Time points | |||||
| Parameter | Pre-Study | Week 4 b | Week 8 | Week 12 | p-value c |
| Phosphorus
(mg/dL) a | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2 ± 0.17 | ≤0.01 |
| Calcium
(mg/dL) a | 8.9 ± 0.09 | 9.5 ± 0.10 | 9.7 ± 0.10 | 9.7 ± 0.10 | ≤0.01 |
a Values expressed as mean ± SE.
b Ninety-one patients completed at least 6 weeks of the study.
c ANOVA of difference in values at pre-study and study completion.
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum calcium increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of calcium acetate is shown in the Table 3.
|
Table 3: Serum Phosphorous and Calcium Levels at Study Initiation
and After Completion of Each Treatment Arm | ||||
| Parameter | Pre-Study | Post-Treatment | p-value b | |
|
Calcium
Acetate | Placebo | |||
| Phosphorus
(mg/dL) a | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
| Calcium
(mg/dL) a | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
a Values expressed as mean ± SEM
b ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
Overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
Calcium Acetate Capsules, 667 mg are hard gelatin capsules with white opaque body imprinted with “590” and light-blue opaque cap imprinted with “AMNEAL” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.
They are available as follows:
Bottles of 200: NDC 42291-189-20
STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Inform patients to take calcium acetate with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after calcium acetate.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 11-2015-01
AV Rev. 06/18 (P)
AvKARE
NDC
42291-189-20
Calcium Acetate Capsules
667 mg*
200 Capsules Rx Only
*Each capsule contains: 667 mg calcium acetate, USP equivalent to 169 mg calcium.
DIRECTIONS: SWALLOW CAPSULES. DO NOT CHEW. Take as directed by your physician.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room
Temperature].
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 10-2014-00 AV 03/15 (P)
N3 42291 18920 1
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-189-20 | EA - Each | 42291-189 | ebefc115-c664-49ed-9dc9-d28608fe850a | 1 | 2015-05-05 |
| 65162-590-20 | EA - Each | 65162-590 | 1185a975-24c4-4371-ae5a-05e9dc6577ff | 1 | 2015-01-05 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CALCIUM ACETATE | ACTIVE INGREDIENT | Y882YXF34X | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| METHYL ALCOHOL | INACTIVE INGREDIENT | Y4S76JWI15 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42291-189 | 42291-189-20 |
| 65162-590 |
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 |
|---|---|---|---|---|---|---|
| BUTYL ALCOHOL | BUTYL ALCOHOL | 8PJ61P6TS3 | TABLET, DELAYED RELEASE / ORAL | 0.05 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, FILM COATED / ORAL | 120 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, COATED / ORAL | 30 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | FILM / SUBLINGUAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE / ORAL | 34.48 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA |
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 |
|---|---|---|---|---|---|---|---|
| A201658-001 | CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 |
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 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | AB | 2014-10-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A201658-001 | CALCIUM ACETATE | 667MG | CAPSULE / ORAL | 2014-10-06 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A201658-001 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201658-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201658-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201658-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201658-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201658-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201658-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201658-001 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| d4c99fe9-2bbd-f2fa-e053-2a95a90a74c3 | c2389f56-6497-e036-d129-8a4870bca30c | 2022-01-04 | Warnings, Adverse reactions | c2389f56-6497-e036-d129-8a4870bca30c |
Adverse event summaries are temporarily unavailable. Other product information remains available.