Medicine
Tretinoin 0.01% gel
Tretinoin 0.01% gel is a generic prescription medicine for topical use, made by 5 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
Conditions: Tretinoin Gel, 0.025% and 0.01%: store below 86°F. Tretinoin…
Key facts
- Active ingredient (INN)
- Tretinoin
- Brand
- Sold under the generic name
- Strength
- 0.01%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 6 more
- Manufacturers
- Aurobindo PharmaIndiaEncube EthicalsMylan PharmaceuticalsPadagisBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Conditions: Tretinoin Gel, 0.025% and 0.01%: store below 86°F. Tretinoin Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AD01 Tretinoin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 March 2017
- Identifiers
- RxCUI 106302, 106303, 198300 +2DailyMed set ID ba377a5e-e48a-4bd9-9d76-929d70793396, 4889c7f8-37d0-4f1a-9829-bca107806586, 04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb +2NDC 0378-8085, 0574-2301, 71335-2952 +2Application NDA017955, ANDA075589, ANDA218246 +1
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 |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 59651-712-14 | Aurobindo PharmaIndia | 13 January 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 59651-712-46 | Aurobindo PharmaIndia | 13 January 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-056-04 | Encube Ethicals | 6 March 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 21922-056-06 | Encube Ethicals | 6 March 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 0378-8085-15 | Mylan Pharmaceuticals | 12 August 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 0378-8085-45 | Mylan Pharmaceuticals | 12 August 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 0574-2301-15 | Padagis | 28 July 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 0574-2301-45 | Padagis | 30 March 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 71335-2952-1 | Bryant Ranch Prepack | 21 October 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 20 October 1971 | 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 Tretinoin 0.01% gel.
Other strengths and forms of Tretinoin
Clinical summary
Tretinoin is a retinoid indicated for topical application in the treatment of acne vulgaris. It is available as cream, gel and capsules for topical and oral use. MedsAcross supplies Tretinoin 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 TretinoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tretinoin Cream prescribing information (Obagi Cosmeceuticals) · U.S. National Library of Medicine, DailyMed
Need Tretinoin 0.01% 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.