Medicine
Estradiol 0.5 mg tablet
Estradiol 0.5 mg tablet is a generic prescription medicine for oral use, made by 13 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 33 more
- Manufacturers
- Bryant Ranch PrepackA-S Medication SolutionsPreferred PharmaceuticalsAsclemedEpic PharmaNorthwind HealthPuraCap LaboratoriesANI PharmaceuticalsCouplerDirect_Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03CA03 Estradiol
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 October 1997
- Identifiers
- RxCUI 197657, 197658, 197659DailyMed set ID 47e446f8-ac16-ea6b-e063-6394a90a1726, 97ace322-341a-4d52-8c63-17265ed9aa8d, 3fe899db-a8cd-4a31-88fb-1129be96b4d9 +15NDC 72189-655, 24658-702, 70954-564 +14Application ANDA217334, ANDA040275, ANDA040197
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 70954-564-10 | ANI Pharmaceuticals | 6 September 2023 |
| 100 tablet in 1 bottle | 42806-087-01 | Epic Pharma | 10 April 2017 |
| 500 tablet in 1 bottle | 42806-087-05 | Epic Pharma | 10 April 2017 |
| 100 tablet in 1 bottle | 24658-702-01 | Puracap Laboratories | 10 September 2021 |
| 500 tablet in 1 bottle | 24658-702-05 | Puracap Laboratories | 10 September 2021 |
| 100 tablet in 1 bottle | 0555-0899-02 | Teva Pharmaceuticals | 28 October 1997 |
| 100 tablet in 1 bottle | 63629-8802-1 | Bryant Ranch Prepack | 4 April 2024 |
| 30 tablet in 1 bottle | 71335-0226-1 | Bryant Ranch Prepack | 29 June 2018 |
| 100 tablet in 1 bottle | 71335-0226-2 | Bryant Ranch Prepack | 27 December 2021 |
| 90 tablet in 1 bottle | 71335-0226-3 | Bryant Ranch Prepack | 7 May 2018 |
| 60 tablet in 1 bottle | 71335-0226-4 | Bryant Ranch Prepack | 27 December 2021 |
| 30 tablet in 1 bottle | 71335-0430-1 | Bryant Ranch Prepack | 4 September 2015 |
| 100 tablet in 1 bottle | 71335-0430-2 | Bryant Ranch Prepack | 4 September 2015 |
| 90 tablet in 1 bottle | 71335-0430-3 | Bryant Ranch Prepack | 4 September 2015 |
| 60 tablet in 1 bottle | 71335-0430-4 | Bryant Ranch Prepack | 4 September 2015 |
| 30 tablet in 1 bottle | 71335-2892-1 | Bryant Ranch Prepack | 28 October 2025 |
| 100 tablet in 1 bottle | 71335-2892-2 | Bryant Ranch Prepack | 28 October 2025 |
| 90 tablet in 1 bottle | 71335-2892-3 | Bryant Ranch Prepack | 28 October 2025 |
| 60 tablet in 1 bottle | 71335-2892-4 | Bryant Ranch Prepack | 28 October 2025 |
| 30 tablet in 1 bottle | 50090-1882-0 | A-S Medication Solutions | 16 June 2015 |
| 90 tablet in 1 bottle | 50090-1882-1 | A-S Medication Solutions | 20 February 2019 |
| 30 tablet in 1 bottle | 50090-5494-0 | A-S Medication Solutions | 17 March 2021 |
| 90 tablet in 1 bottle | 50090-5494-1 | A-S Medication Solutions | 17 March 2021 |
| 100 tablet in 1 bottle | 76420-021-10 | Asclemed | 29 September 2020 |
| 30 tablet in 1 bottle | 76420-021-30 | Asclemed | 16 December 2019 |
| 90 tablet in 1 bottle | 76420-021-90 | Asclemed | 16 December 2019 |
| 30 tablet in 1 blister pack | 67046-1568-3 | Coupler | 17 June 2025 |
| 60 tablet in 1 bottle | 72189-655-60 | Direct_Rx | 8 January 2026 |
| 100 tablet in 1 bottle | 72603-273-01 | NorthStar Rx | 10 July 2024 |
| 90 tablet in 1 bottle, plastic | 51655-860-26 | Northwind Health | 4 May 2023 |
| 30 tablet in 1 bottle, plastic | 51655-860-52 | Northwind Health | 9 February 2023 |
| 30 tablet in 1 bottle, plastic | 72789-489-30 | PD-Rx Pharmaceuticals | 20 February 2025 |
| 100 tablet in 1 bottle | 68788-8626-1 | Preferred Pharmaceuticals | 9 April 2024 |
| 30 tablet in 1 bottle | 68788-8626-3 | Preferred Pharmaceuticals | 9 April 2024 |
| 60 tablet in 1 bottle | 68788-8626-6 | Preferred Pharmaceuticals | 9 April 2024 |
| 90 tablet in 1 bottle | 68788-8626-9 | Preferred Pharmaceuticals | 9 April 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 10 September 1986 | 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
Other strengths and forms of Estradiol
Clinical summary
Estradiol is an estrogen indicated for climara is an estrogen indicated for, among other approved uses. It is available as transdermal patches, tablets and gel for oral and topical use. MedsAcross supplies Estradiol 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 EstradiolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Climara prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Estradiol 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.