Medicine
Ethinyl estradiol and Norethindrone 0.02 mg/1 mg tablet
Ethinyl estradiol and Norethindrone 0.02 mg/1 mg tablet is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Ethinyl estradiol and Norethindrone
- Brand
- Sold under the generic name
- Strength
- 0.02 mg/1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 pouches, 1 blister pack, 28 tablets and 1 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaA-S Medication SolutionsDirect_RxMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 July 2014
- Identifiers
- RxCUI 1358762, 1358776DailyMed set ID 38924c83-53aa-4279-8f0e-1a5d8f5fd8ad, 89948751-bd6e-4e9c-b87c-8782706c1097, 5a44f7a2-45f1-4d28-b9fb-61d9f2456422 +1NDC 50090-6782, 0378-7280, 68462-132 +1Application ANDA206969, ANDA202771, ANDA076380
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack | 68462-132-81 | Glenmark PharmaceuticalsIndia | 20 January 2016 |
| 3 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack | 0378-7280-53 | Mylan Pharmaceuticals | 7 November 2014 |
| 1 blister pack in 1 carton / 21 tablet in 1 blister pack | 50090-6782-0 | A-S Medication Solutions | 30 October 2023 |
| 28 tablet in 1 pouch | 72189-215-28 | Direct_Rx | 6 October 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 April 1973 | 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Ethinyl estradiol and Norethindrone 0.02 mg/1 mg tablet.
Other strengths and forms of Ethinyl estradiol and Norethindrone
Clinical summary
Ethinyl estradiol and Norethindrone is a fixed-dose combination of an estrogen and a progestin indicated in a woman with a uterus for treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. MedsAcross supplies Ethinyl estradiol and Norethindrone 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
Read about Ethinyl estradiol and NorethindroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Norethindrone Acetate and Ethinyl Estradiol prescribing information (Glenmark Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ethinyl estradiol and Norethindrone 0.02 mg/1 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.