Medicine
Estradiol and Norethindrone 1 mg/0.5 mg tablet
Estradiol and Norethindrone 1 mg/0.5 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Estradiol and Norethindrone
- Brand
- Sold under the generic name
- Strength
- 1 mg/0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 6 blister pack, 3 blister pack and 3 more
- Manufacturers
- Ingenus PharmaceuticalsA-S Medication SolutionsBreckenridge PharmaceuticalNaari
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store in a dry place protected from light.
- 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
- 17 April 2008
- Identifiers
- RxCUI 1359123, 1359124, 1359126 +1DailyMed set ID 50c786d6-91bd-4eea-9455-ff2abc08372f, f70185fe-9fcf-655f-e053-6394a90a20dc, e166bdf6-eb60-49b8-9747-2a33c3e3461b +1NDC 50742-657, 79929-012, 50090-8003 +1Application ANDA210612, ANDA210233, ANDA078324
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 |
|---|---|---|---|
| 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack | 51991-474-28 | Breckenridge Pharmaceutical | 17 April 2008 |
| 1 blister pack in 1 carton / 28 tablet in 1 blister pack | 50742-657-28 | Ingenus Pharmaceuticals | 3 April 2019 |
| 6 blister pack in 1 carton / 28 tablet in 1 blister pack | 50742-657-68 | Ingenus Pharmaceuticals | 3 April 2019 |
| 3 blister pack in 1 carton / 28 tablet in 1 blister pack | 50742-657-84 | Ingenus Pharmaceuticals | 3 April 2019 |
| 84 blister pack in 1 pouch / 28 tablet in 1 blister pack | 79929-012-07 | Naari | 11 June 2024 |
| 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack | 50090-8003-0 | A-S Medication Solutions | 25 June 2026 |
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 7 August 1998 | 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 Estradiol and Norethindrone 1 mg/0.5 mg tablet.
- Etyqa 1 mg/0.5 mg tabletAvailable on requestAurobindo PharmaIndiaUS FDA2 packs
- Lopreeza 1 mg/0.5 mg tabletAvailable on requestAmneal Pharmaceuticals NYUS FDA2 packs
- Mimvey 1 mg/0.5 mg tabletAvailable on requestTeva PharmaceuticalsUS FDA2 packs
- Abigale 1 mg/0.5 mg tabletAvailable on requestXiromedUS FDA1 pack
- Activella 1 mg/0.5 mg tabletAvailable on requestAmneal PharmaceuticalsUS FDA1 pack
Other strengths and forms of Estradiol and Norethindrone
Clinical summary
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 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 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
- CombiPatch (estradiol/norethindrone acetate transdermal system) prescribing information (Noven Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Estradiol and Norethindrone 1 mg/0.5 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.