Fixed-dose combination
Ethinyl estradiol and Levonorgestrel is a fixed-dose combination of an estrogen, a progestin and a progestin-containing intrauterine system indicated by females of reproductive potential to prevent pregnancy. MedsAcross supplies Ethinyl estradiol and Levonorgestrel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.
Source: US FDA prescribing information
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Source: US FDA prescribing information
Take one tablet by mouth at the same time every day. Take tablets in the order directed on the blister pack. How to Start Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are dispensed in a blister card. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets may be started using either a Day 1 start or a Sunday start. 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.
Source: US FDA prescribing information
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic disease. Examples include women who are known to: Smoke, if over age 35. Have deep vein thrombosis or pulmonary embolism, now or in the past. Have inherited or acquired hypercoagulopathies. Have cerebrovascular disease. Have coronary artery disease. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation). Have uncontrolled hypertension.
Source: US FDA prescribing information
Boxed warning (cigarette smoking and serious cardiovascular events): 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 are contraindicated in women who are over 35 years of age and smoke. Thrombotic Disorders and Other Vascular Problems: Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Liver disease: Discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if jaundice occurs.
Source: US FDA prescribing information
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke Vascular events Liver disease Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each)
Source: US FDA prescribing information
Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.
Source: US FDA prescribing information
Storage Conditions Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light Keep out of the reach of children.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Ethinyl estradiol and Levonorgestrel, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Balcoltra kit | Ethinyl estradiol and Levonorgestrel | Avion Pharmaceuticals | US FDA | Available on request |
| Dolishale 20 mcg/90 mcg tabletOral | Ethinyl estradiol and Levonorgestrel | Ingenus Pharmaceuticals | US FDA | Available on request |
| Ethinyl estradiol and Levonorgestrel kitGeneric name | Ethinyl estradiol and Levonorgestrel | — | US FDA | Available on request |
| Twirla 2.3 mg/2.6 mg transdermal patchTransdermal | Ethinyl estradiol and Levonorgestrel | Agile Therapeutics | US FDA | Available on request |
| Amethyst 20 mcg/90 mcg tabletOral | Ethinyl estradiol and Levonorgestrel | Teva Pharmaceuticals | US FDA | Available on request |
| Ethinyl estradiol and Levonorgestrel 20 mcg/90 mcg tabletOralGeneric name | Ethinyl estradiol and Levonorgestrel | — | US FDA | Available on request |
| Tyblume kit | Ethinyl estradiol and Levonorgestrel | Exeltis | US FDA | Available on request |
5 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 10 May 1982 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 7 presentations of Ethinyl estradiol and Levonorgestrel and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 5 brand names for Ethinyl estradiol and Levonorgestrel, including Amethyst, Balcoltra, Dolishale, Twirla, Tyblume.
Yes. The US FDA first approved Ethinyl estradiol and Levonorgestrel on 10 May 1982, according to Drugs@FDA.
No listed presentation of Ethinyl estradiol and Levonorgestrel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.