Medicine
Estradiol Vaginal 0.01% vaginal cream
Estradiol Vaginal 0.01% vaginal cream is a prescription medicine containing Estradiol for vaginal use, marketed by Padagis Israel Pharmaceuticals, 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 room temperature 20° to 25°C (68° to 77°F). Protect from temperatures…
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Estradiol Vaginal
- Strength
- 0.01%
- Dosage form
- Vaginal cream
- Route
- Vaginal
- Packs
- 1 tube and 5 more
- Marketing authorisation holder
- Padagis Israel Pharmaceuticals
- Manufacturers
- Padagis Israel PharmaceuticalsBryant Ranch PrepackA-S Medication SolutionsAvKARENuCare Pharmaceuticals,IncRedpharm Drug
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20° to 25°C (68° to 77°F). Protect from temperatures in excess of 40°C (104°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
- 6 January 2021
- Identifiers
- RxCUI 310169DailyMed set ID e7b15ec3-e195-44a6-bdd7-9b6de2b235b8, f76232ed-b109-43d1-bf2e-d41b6420c37d, 546c168d-2a85-69b6-e063-6294a90a22ac +5NDC 63629-8654, 45802-097, 67296-2258 +5Application ANDA210194
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 |
|---|---|---|---|
| 1 tube in 1 carton / 42.5 g in 1 tube | 45802-097-35 | Padagis Israel Pharmaceuticals | 6 January 2021 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 63629-8654-1 | Bryant Ranch Prepack | 6 January 2021 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 71335-2831-1 | Bryant Ranch Prepack | 23 October 2025 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 72162-1389-2 | Bryant Ranch Prepack | 6 January 2021 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 50090-7266-0 | A-S Medication Solutions | 7 October 2024 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 42291-426-42 | AvKARE | 16 February 2021 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 68071-3796-4 | NuCare Pharmaceuticals | 17 February 2025 |
| 1 tube in 1 carton / 42.5 g in 1 tube | 67296-2258-4 | Redpharm Drug | 6 January 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 0.01% vaginal cream.
- Estradiol 0.01% vaginal creamAvailable on request—US FDA6 packs
- Estrace 0.01% vaginal creamAvailable on requestAllerganUS FDA2 packs
- Estradiol Vaginal 0.01% vaginal creamAvailable on requestEncube EthicalsUS FDA2 packs
- Estradiol Vaginal 0.01% vaginal creamAvailable on requestA-S Medication SolutionsUS FDA1 pack
- Estradiol Vaginal Cream 0.01% vaginal creamAvailable on requestPrasco LaboratoriesUS FDA1 pack
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 0.01% vaginal cream 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.