Medicine
Estradiol Vaginal Inserts 10 mcg vaginal tablet
Estradiol Vaginal Inserts 10 mcg vaginal tablet is a prescription medicine containing Estradiol for vaginal use, marketed by Aurobindo Pharma, 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), excursions permitted…
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Estradiol Vaginal Inserts
- Strength
- 10 mcg
- Dosage form
- Vaginal tablet
- Route
- Vaginal
- Packs
- 8 applicators, 18 applicators and 1 more
- Marketing authorisation holder
- Aurobindo Pharma
- Manufacturers
- Aurobindo PharmaIndiaNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate. 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
- 2 August 2024
- Identifiers
- RxCUI 884707DailyMed set ID 6247e329-e20e-4ea5-9cc1-b593bd494577, ad203bfd-28da-45a3-b9c0-7f886eb03634NDC 59651-439, 72603-874Application ANDA216550
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 8 applicator in 1 carton / 1 tablet, film coated in 1 applicator | 59651-439-08 | Aurobindo PharmaIndia | 2 August 2024 |
| 18 applicator in 1 carton / 1 tablet, film coated in 1 applicator | 59651-439-18 | Aurobindo PharmaIndia | 2 August 2024 |
| 8 applicator in 1 carton / 1 tablet, film coated in 1 applicator | 72603-874-08 | NorthStar Rx | 1 September 2025 |
| 18 applicator in 1 carton / 1 tablet, film coated in 1 applicator | 72603-874-18 | NorthStar Rx | 1 September 2025 |
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 tablet.
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 Vaginal Inserts 10 mcg vaginal 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.