Medicine
Norethindrone 5 mg tablet
Norethindrone 5 mg tablet is a generic prescription medicine for oral use, made by 7 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 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Norethindrone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 50 tablets, 30 tablets and 8 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaAmneal PharmaceuticalsAmerican Health PackagingAvKAREGolden State Medical SupplyIngenus PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03AC01 Norethindrone
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 May 2001
- Identifiers
- RxCUI 1000405DailyMed set ID 64cb920c-36e8-4d62-9d08-3ddf3989d313, d0a94321-eb60-4aa6-a429-f0156f9f8e01, 2bb29135-6e9b-a9e2-e063-6394a90ae9e4 +4NDC 65162-475, 68462-304, 51407-599 +4Application ANDA200275, ANDA091090, ANDA075951 +1
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 |
|---|---|---|---|
| 500 tablet in 1 bottle | 68462-304-05 | Glenmark PharmaceuticalsIndia | 21 July 2010 |
| 50 tablet in 1 bottle | 68462-304-50 | Glenmark PharmaceuticalsIndia | 21 July 2010 |
| 30 tablet in 1 bottle | 65162-475-03 | Amneal Pharmaceuticals | 1 July 2009 |
| 50 tablet in 1 bottle | 65162-475-05 | Amneal Pharmaceuticals | 1 July 2009 |
| 90 tablet in 1 bottle | 65162-475-09 | Amneal Pharmaceuticals | 1 July 2009 |
| 500 tablet in 1 bottle | 65162-475-50 | Amneal Pharmaceuticals | 1 July 2009 |
| 50 tablet in 1 bottle | 50742-267-50 | Ingenus Pharmaceuticals | 29 August 2019 |
| 50 tablet in 1 bottle | 0555-0211-10 | Teva Pharmaceuticals | 29 June 2001 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-921-21 | American Health Packaging | 14 January 2026 |
| 90 tablet in 1 bottle | 42291-650-90 | AvKARE | 18 June 2013 |
| 50 tablet in 1 bottle | 51407-599-50 | Golden State Medical Supply | 20 December 2024 |
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 2 January 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 Norethindrone 5 mg tablet.
Other strengths and forms of Norethindrone
Clinical summary
Norethindrone is a progestin indicated for the prevention of pregnancy. It is available as tablets for oral use. MedsAcross supplies 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 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
- Nora BE prescribing information (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Norethindrone 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.