Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (...
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy.
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED ). Levonorgestrel and ethinyl estradiol tablets may be started using either a Day 1 start or a Sunday start (see Table 3 ). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administrat...
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/30 mcg are available in a carton of 3 pouches and a carton of 6 pouches, each pouch contains 28 tablets: 21 Active Tablets: White to off-white, round, unscored tablets debossed with 209 on one side and plain on the other side. 7 Inert Tablets: Green, round, unscored tablets debossed with 274 on one side and plain on the other side. NDC 0378-6550-53, cartons...
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg are a combination oral contraceptives (COC) consisting of 21 white to off-white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 green inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel
C21H28O2 MW: 312.45
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-.
Ethinyl Estradiol
C20H24O2 MW: 296.40
Ethinyl Estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
Each white to off-white active tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and polacrilin potassium.
Each green inert tablet contains the following inactive ingredients: FD&C Blue No. 1 aluminum lake, lactose monohydrate, magnesium stearate, polacrilin potassium, and yellow oxide of iron.
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have the following conditions:
Arterial Events
COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS). Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Venous Events
Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS). While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years.
The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.
Figure 1 Likelihood of Developing a VTE
Elevated Liver Enzymes
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS). Discontinue levonorgestrel and ethinyl estradiol tablets if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded.
Liver Tumors
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with benign or malignant liver tumors (see CONTRAINDICATIONS). COCs increase the risk of hepatic adenomas. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death from abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. The attributable risk of liver cancers in COC users is less than one case per million users.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with uncontrolled hypertension or hypertension with vascular disease (see CONTRAINDICATIONS). For all females, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop levonorgestrel and ethinyl estradiol tablets if blood pressure rises significantly.
An increase in blood pressure has been reported in females using COCs, and this increase is more likely in older women with extended duration of use. The effect of COCs on blood pressure may vary according to the progestin in the COC.
The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Certain conditions, such as smoking and migraine headache without aura, that do not contraindicate COC use in younger females, are contraindications to use in women over 35 years of age [see CONTRAINDICATIONS and WARNINGS (1)]. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating a COC for women over 35 years, such as:
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue levonorgestrel and ethinyl estradiol tablets prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see CONTRAINDICATIONS). Levonorgestrel and ethinyl estradiol tablets can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
Studies suggest an increased risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis.
Hyperglycemia
Levonorgestrel and ethinyl estradiol tablets are contraindicated in diabetic women over age 35, or females who have diabetes with hypertension, nephropathy, retinopathy, neuropathy, other vascular disease, or females with diabetes of > 20 years duration (see CONTRAINDICATIONS). Levonorgestrel and ethinyl estradiol tablets may decrease glucose tolerance. Carefully monitor prediabetic and diabetic females who are using levonorgestrel and ethinyl estradiol tablets.
Dyslipidemia
Consider alternative contraception for females with uncontrolled dyslipidemia. Levonorgestrel and ethinyl estradiol tablets may cause adverse lipid changes.
Females with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using levonorgestrel and ethinyl estradiol tablets which may increase the risk of pancreatitis.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine headaches with or without aura (see CONTRAINDICATIONS).
If a woman using levonorgestrel and ethinyl estradiol tablets develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue levonorgestrel and ethinyl estradiol tablets if indicated. Consider discontinuation of levonorgestrel and ethinyl estradiol tablets if there is an increased frequency or severity of migraines during COC use (which may be prodromal of a cerebrovascular event).
Unscheduled Bleeding and Spotting
Females using levonorgestrel and ethinyl estradiol tablets may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy.
In two clinical trials of levonorgestrel and ethinyl estradiol tablets (1084 subjects reporting for a total of 8186 treatment cycles and 238 subjects reporting for a total of 1102 treatment cycles), breakthrough bleeding occurred in 6.9% and 8.1% of reported cycles, and spotting occurred in 8.6% and 7.9% of reported cycles over the total study duration, respectively. In the two trials, intermenstrual bleeding (i.e., breakthrough bleeding and/or spotting) occurred in 13.1% and 12.9% of reported cycles over the total study duration, respectively. In one trial, 33 subjects out of 1084 (3.0%) discontinued due to bleeding irregularities (i.e., breakthrough bleeding and spotting); in the other trial, 6 subjects out of 238 (2.5%) discontinued due to bleeding irregularities.
Amenorrhea and Oligomenorrhea
Females who use levonorgestrel and ethinyl estradiol tablets may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. In two clinical trials of levonorgestrel and ethinyl estradiol tablets, one including 8186 reported treatment cycles, and the other including 1102 reported treatment cycles, amenorrhea occurred in 1.5% of treatment cycles in each trial.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
After discontinuation of a COC, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.
Carefully observe females with a history of depression and discontinue levonorgestrel and ethinyl estradiol tablets if depression recurs to a serious degree. Data on the association of COCs with onset of depression or exacerbation of existing depression are limited.
Breast Cancer
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [seeCONTRAINDICATIONS].
Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use (see ADVERSE REACTIONS, Post Marketing Experience).
Cervical Cancer
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. There is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.
The estrogen component of levonorgestrel and ethinyl estradiol tablets may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma may occur with levonorgestrel and ethinyl estradiol tablets use, especially in females with a history of chloasma gravidarum. Advise females with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while using levonorgestrel and ethinyl estradiol tablets.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult [see WARNINGS (7)].
In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
Diarrhea and/or vomiting may reduce hormone absorption (see DOSAGE AND ADMINISTRATION).
The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.
No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets.
Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs:
Table 1 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets.
Metabolic Enzyme Inducers | |
Clinical effect |
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Prevention or management |
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Examples | Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort*, and certain protease inhibitors (see separate section on protease inhibitors below). |
Colesevelam | |
Clinical effect |
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Prevention or management | Administer 4 or more hours apart to attenuate this drug interaction. |
* Induction potency of St. John’s wort may vary widely based on preparation
Substances increasing the systemic exposure of COCs:
Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs.
Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:
Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine).
In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).
Table 2 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablets.
Lamotrigine | |
Clinical effect |
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Prevention or management | Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine. |
Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy | |
Clinical effect | Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin (see Warnings, EFFECT ON BINDING GLOBULINS). |
Prevention or management | The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use (see Warnings, EFFECT ON BINDING GLOBULINS). |
Other Drugs | |
Clinical effect | Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
Prevention or management | The dosage of drugs that can be affected by this interaction may need to be increased. Consult the approved product labeling for the concomitantly used drug. |
Do not co-administer levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, [see Warnings (5)], and glecaprevir/pibrentasvir due to potential for ALT elevations.
The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
See WARNINGS (11).
Risk Summary
Discontinue levonorgestrel and ethinyl estradiol tablets if pregnancy occurs because there is no reason to use COCs in pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. Animal studies to evaluate embryo/fetal toxicity were not conducted.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Risk Summary
Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. (see DOSAGE AND ADMINISTRATION). The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for levonorgestrel and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from levonorgestrel and ethinyl estradiol tablets or from the underlying maternal condition.
Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in females of reproductive potential. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated.
Levonorgestrel and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions reported by COC users and described elsewhere in the labeling are:
Post Marketing Experience
Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.
Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives
RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.
There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED). Levonorgestrel and ethinyl estradiol tablets may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
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Starting Levonorgestrel and Ethinyl Estradiol Tablets after Abortion or Miscarriage
First-trimester
Second-trimester
Starting Levonorgestrel and Ethinyl Estradiol Tablets after Childbirth
Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take levonorgestrel and ethinyl estradiol tablets as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.
Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.
| Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. |
| Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
| Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
If vomiting occurs within 3 to 4 hours after taking levonorgestrel and ethinyl estradiol tablets, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/30 mcg are available in a carton of 3 pouches and a carton of 6 pouches, each pouch contains 28 tablets:
21 Active Tablets: | White to off-white, round, unscored tablets debossed with 209 on one side and plain on the other side. |
7 Inert Tablets: | Green, round, unscored tablets debossed with 274 on one side and plain on the other side. |
NDC 0378-6550-53, cartons of 3 pouches, each pouch containing 28 tablets | |
NDC 0378-6550-56, cartons of 6 pouches, each pouch containing 28 tablets |
Store at 20° to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Levonorgestrel and ethinyl estradiol tablets are a birth control pills (oral contraceptive) used by women to prevent pregnancy.
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use levonorgestrel and ethinyl estradiol tablets.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Do not take levonorgestrel and ethinyl estradiol tablets if you:
If any of these conditions happen while you are taking levonorgestrel and ethinyl estradiol tablets, stop taking levonorgestrel and ethinyl estradiol tablets right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking levonorgestrel and ethinyl estradiol tablets.
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Levonorgestrel and ethinyl estradiol tablets may affect the way other medicines work, and other medicines may affect how well levonorgestrel and ethinyl estradiol tablets work.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Read the Instructions for Use at the end of this Patient Information.
Call your healthcare provider or go to a hospital emergency room right away if you have:
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Other serious side effects include:
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These are not all the possible side effects of levonorgestrel and ethinyl estradiol tablets. For more information, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use levonorgestrel and ethinyl estradiol tablets for a condition for which it was not prescribed. Do not give levonorgestrel and ethinyl estradiol tablets to other people, even if they have the same symptoms that you have.
This Patient Information Leaflet summarizes the most important information about levonorgestrel and ethinyl estradiol tablets. You can ask your pharmacist or healthcare provider for information about levonorgestrel and ethinyl estradiol tablets that is written for health professionals.
For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking levonorgestrel and ethinyl estradiol tablets, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
Active ingredients: Each white to off-white pill contains levonorgestrel and ethinyl estradiol.
Inactive ingredients:
White to off-white pills: lactose monohydrate, magnesium stearate, and polacrilin potassium.
Green pills: FD&C Blue No. 1 aluminum lake, lactose monohydrate, magnesium stearate, polacrilin potassium, and yellow oxide of iron.
If you start taking levonorgestrel and ethinyl estradiol tablets and you have not used a hormonal birth control method before:
If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from another birth control pill:
If you start taking levonorgestrel and ethinyl estradiol tablets and previously used a vaginal ring:
If you start taking levonorgestrel and ethinyl estradiol tablets and previously used a transdermal patch:
If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from a progestin-only method such as an implant or injection:
If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from an intrauterine device or system (IUD or IUS):
Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, “When should I start taking levonorgestrel and ethinyl estradiol tablets?” above. Follow these instructions for either a Sunday Start or a Day 1 Start.
Sunday Start:
You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.
Day 1 Start:
You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period.
If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:
If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Ahmedabad - 382 213, India
Code No.: GUJ-DRUGS/G/28/1297
75092137
Revised: 7/2022
FC:A:OT:6550:R10
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 19 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 19 |
| 748797 | inert 1 MG Oral Tablet | PSN | 19 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 19 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 19 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 19 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ETHINYL ESTRADIOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| LEVONORGESTREL Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230718 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-6550-53 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 3 in 1 CARTON | KIT | 3 | 19 | |
| 0378-6550-85 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 1 in 1 BLISTER PACK | KIT | 1 | 19 | |
| 0378-6550-85 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 1 in 1 POUCH | KIT | 1 | 19 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-6550-53 | EA - Each | 0378-6550 | 7c39e2f5-8f91-4700-a739-ebb3ab36f985 | 1 | 2013-02-13 |
| 0378-6550-85 | EA - Each | 0378-6550 | 1b7d2373-4131-4aeb-ae56-9baaebf516dc | 1 | 2018-11-06 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | 5 | |
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | 5 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | 5 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0378-6550 | 0378-6550-85, 0378-6550-53 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ETHINYL ESTRADIOL | 423D2T571U | ACTIB |
| LEVONORGESTREL | 5W7SIA7YZW | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POLACRILIN POTASSIUM | 0BZ5A00FQU | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POLACRILIN POTASSIUM | 0BZ5A00FQU | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / RESPIRATORY (INHALATION) | 25 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, CHEWABLE / ORAL | 14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| POLACRILIN POTASSIUM | POLACRILIN POTASSIUM | 0BZ5A00FQU | SOLUTION / ORAL | 35 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, ORALLY DISINTEGRATING / ORAL | 366 mg | ||
| POLACRILIN POTASSIUM | POLACRILIN POTASSIUM | 0BZ5A00FQU | SUSPENSION / ORAL | 120 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / SUBLINGUAL | 1 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INHALANT / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / ORAL | 50 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / INTRAMUSCULAR | 150 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE / ORAL | 3990 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 |
| Application-product | TE code |
|---|---|
| A091663-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091663-001 | LEVONORGESTREL AND ETHINYL ESTRADIOL | 0.03MG;0.15MG | TABLET / ORAL-28 | AB | 2012-12-21 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091663-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091663-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091663-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091663-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091663-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091663-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091663-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091663-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091663-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091663-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091663-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091663-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091663-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091663-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091663-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091663-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091663-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091663-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091663-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091663-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091663-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091663-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091663-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091663-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091663-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091663-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091663-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091663-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091663-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091663-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091663-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091663-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091663-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091663-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091663-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091663-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091663-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091663-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091663-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091663-001 | AB | 1 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| feeae783-e2d6-4d6f-9815-627228a6b23b | 27178b07-42bd-496d-aebb-d9428664ee72 | 2022-07-31 | Boxed warning, Warnings, Adverse reactions | feeae783-e2d6-4d6f-9815-627228a6b23b 27178b07-42bd-496d-aebb-d9428664ee72 |
Adverse event summaries are temporarily unavailable. Other product information remains available.