Medicine
Estradiol 10 mcg vaginal insert
Estradiol 10 mcg vaginal insert is a generic prescription medicine for vaginal use, made by 3 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
Do not refrigerate. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Sold under the generic name
- Strength
- 10 mcg
- Dosage form
- Vaginal insert
- Route
- Vaginal
- Packs
- 8 applicators, 18 applicators, 8 blister pack and 3 more
- Manufacturers
- Amneal Pharmaceuticals of New YorkBryant Ranch PrepackTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate. 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
- ATC code
- G03CA03 Estradiol
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 June 2015
- Identifiers
- RxCUI 884707DailyMed set ID 7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32, 8cb31c7c-fba8-4201-833d-844ea1a8a4de, d9514497-6b9e-4c13-950b-6b036ff101c1 +1NDC 63629-8803, 0093-3223, 63629-8804 +1Application ANDA206388, ANDA205256
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 |
|---|---|---|---|
| 8 applicator in 1 carton / 1 insert in 1 applicator | 53746-226-21 | Amneal Pharmaceuticals of New York | 7 June 2015 |
| 18 applicator in 1 carton / 1 insert in 1 applicator | 53746-226-23 | Amneal Pharmaceuticals of New York | 7 June 2015 |
| 8 blister pack in 1 carton / 1 applicator in 1 blister pack / 1 insert in 1 applicator | 0093-3223-08 | Teva Pharmaceuticals | 24 July 2017 |
| 18 blister pack in 1 carton / 1 applicator in 1 blister pack / 1 insert in 1 applicator | 0093-3223-97 | Teva Pharmaceuticals | 24 July 2017 |
| 8 blister pack in 1 carton / 1 applicator in 1 blister pack / 1 insert in 1 applicator | 63629-8803-1 | Bryant Ranch Prepack | 10 September 2021 |
| 18 blister pack in 1 carton / 1 applicator in 1 blister pack / 1 insert in 1 applicator | 63629-8804-1 | Bryant Ranch Prepack | 10 September 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 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
Alternatives
Other makers and brands of Estradiol 10 mcg vaginal insert.
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 10 mcg vaginal insert 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.