Medicine
Estradiol 0.1% gel
Estradiol 0.1% gel is a generic prescription medicine for topical use, made by 8 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 to…
Key facts
- Active ingredient (INN)
- Estradiol
- Brand
- Sold under the generic name
- Strength
- 0.1%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 30 packets, 90 packets and 41 more
- Manufacturers
- Trigen LaboratoriesAmneal Pharmaceuticals NYANI PharmaceuticalsEncube EthicalsNorthStar RxPadagis Israel PharmaceuticalsXiromed8 labelers on the register
- 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
- 1 October 2022
- Identifiers
- RxCUI 2619677, 2619679, 2619681 +2DailyMed set ID e84ad638-6768-41aa-b2b8-e2514ef63881, 1a46efe6-21b9-3f0f-90b9-59f279ef51df, 3ac905b3-904c-4285-97ed-e787d006c7dd +8NDC 13811-093, 70700-195, 13811-092 +36Application NDA022038, ANDA211783, ANDA216524 +3
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
A sample of 40 packs from 8 labelers. The register lists 44 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 packet in 1 carton / 1.25 g in 1 packet | 69238-2448-3 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 30 packet in 1 carton / 1 g in 1 packet | 69238-2449-3 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 30 packet in 1 carton / .75 g in 1 packet | 69238-2450-3 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 30 packet in 1 carton / .5 g in 1 packet | 69238-2451-3 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 30 packet in 1 carton / .25 g in 1 packet | 69238-2452-3 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 30 packet in 1 carton / .5 g in 1 packet | 70954-530-20 | ANI Pharmaceuticals | 30 August 2023 |
| 30 packet in 1 carton / .25 g in 1 packet | 70954-531-20 | ANI Pharmaceuticals | 24 August 2023 |
| 30 packet in 1 carton / .75 g in 1 packet | 70954-532-20 | ANI Pharmaceuticals | 24 August 2023 |
| 30 packet in 1 carton / 1 g in 1 packet | 70954-533-20 | ANI Pharmaceuticals | 24 August 2023 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 70954-534-20 | ANI Pharmaceuticals | 24 August 2023 |
| 30 packet in 1 carton / .25 g in 1 packet | 21922-086-52 | Encube Ethicals | 10 March 2025 |
| 30 packet in 1 carton / .5 g in 1 packet | 21922-087-52 | Encube Ethicals | 10 March 2025 |
| 30 packet in 1 carton / .75 g in 1 packet | 21922-088-52 | Encube Ethicals | 10 March 2025 |
| 30 packet in 1 carton / 1 g in 1 packet | 21922-089-52 | Encube Ethicals | 10 March 2025 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 21922-090-52 | Encube Ethicals | 10 March 2025 |
| 30 packet in 1 carton / .25 g in 1 packet | 45802-134-30 | Padagis Israel Pharmaceuticals | 7 December 2023 |
| 30 packet in 1 carton / .5 g in 1 packet | 45802-202-30 | Padagis Israel Pharmaceuticals | 7 December 2023 |
| 30 packet in 1 carton / .75 g in 1 packet | 45802-310-30 | Padagis Israel Pharmaceuticals | 7 December 2023 |
| 30 packet in 1 carton / 1 g in 1 packet | 45802-452-30 | Padagis Israel Pharmaceuticals | 7 December 2023 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 45802-573-30 | Padagis Israel Pharmaceuticals | 7 December 2023 |
| 30 packet in 1 carton / .25 g in 1 packet | 13811-090-32 | Trigen Laboratories | 10 October 2022 |
| 90 packet in 1 carton / .25 g in 1 packet | 13811-090-92 | Trigen Laboratories | 20 August 2026 |
| 30 packet in 1 carton / .5 g in 1 packet | 13811-091-32 | Trigen Laboratories | 10 October 2022 |
| 90 packet in 1 carton / .5 g in 1 packet | 13811-091-92 | Trigen Laboratories | 20 August 2026 |
| 30 packet in 1 carton / .75 g in 1 packet | 13811-092-32 | Trigen Laboratories | 10 October 2022 |
| 90 packet in 1 carton / .75 g in 1 packet | 13811-092-92 | Trigen Laboratories | 20 August 2026 |
| 30 packet in 1 carton / 1 g in 1 packet | 13811-093-32 | Trigen Laboratories | 10 October 2022 |
| 90 packet in 1 carton / 1 g in 1 packet | 13811-093-92 | Trigen Laboratories | 20 August 2026 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 13811-094-32 | Trigen Laboratories | 10 October 2022 |
| 90 packet in 1 carton / 1.25 g in 1 packet | 13811-094-92 | Trigen Laboratories | 20 August 2026 |
| 30 packet in 1 carton / .25 g in 1 packet | 70700-143-35 | Xiromed | 1 October 2022 |
| 30 packet in 1 carton / .5 g in 1 packet | 70700-144-35 | Xiromed | 1 October 2022 |
| 30 packet in 1 carton / 1 g in 1 packet | 70700-145-35 | Xiromed | 1 October 2022 |
| 30 packet in 1 carton / .75 g in 1 packet | 70700-194-35 | Xiromed | 1 October 2022 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 70700-195-35 | Xiromed | 1 October 2022 |
| 30 packet in 1 carton / .25 g in 1 packet | 72603-241-30 | NorthStar Rx | 18 December 2023 |
| 30 packet in 1 carton / .5 g in 1 packet | 72603-242-30 | NorthStar Rx | 18 December 2023 |
| 30 packet in 1 carton / .75 g in 1 packet | 72603-243-30 | NorthStar Rx | 18 December 2023 |
| 30 packet in 1 carton / 1 g in 1 packet | 72603-244-30 | NorthStar Rx | 18 December 2023 |
| 30 packet in 1 carton / 1.25 g in 1 packet | 72603-245-30 | NorthStar Rx | 18 December 2023 |
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 0.1% gel.
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 0.1% gel 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.