Medicine
Tretinoin 0.05% cream
Tretinoin 0.05% cream is a generic prescription medicine for topical use, made by 10 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, USP: store below 30°C (86°F). Tretinoin Cream, USP…
Key facts
- Active ingredient (INN)
- Tretinoin
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube and 16 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaA-S Medication SolutionsEncube EthicalsMylan PharmaceuticalsNorthStar RxPadagisBryant Ranch PrepackNuCare Pharmaceuticals,IncObagi Cosmeceuticals
- Origin register
- US FDA, United States
- Storage
- Conditions: Tretinoin Gel, USP: store below 30°C (86°F). Tretinoin Cream, USP: store below 27°C (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
- 19 July 1974
- Identifiers
- RxCUI 106302, 106303, 198300 +2DailyMed set ID 4889c7f8-37d0-4f1a-9829-bca107806586, 8929196c-389a-4c43-843c-00fbb26a1dd9, 2e508351-eca3-427e-8d16-e840a84db0f5 +9NDC 0574-2205, 72162-2158, 16714-249 +9Application ANDA075265, ANDA211644, ANDA214590 +2
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 / 45 g in 1 tube | 46708-808-00 | Alembic PharmaceuticalsIndia | 11 June 2026 |
| 1 tube in 1 carton / 20 g in 1 tube | 46708-808-20 | Alembic PharmaceuticalsIndia | 11 June 2026 |
| 1 tube in 1 carton / 20 g in 1 tube | 62332-808-20 | Alembic PharmaceuticalsIndia | 11 June 2026 |
| 1 tube in 1 carton / 45 g in 1 tube | 62332-808-45 | Alembic PharmaceuticalsIndia | 11 June 2026 |
| 1 tube in 1 carton / 20 g in 1 tube | 51672-1394-0 | Sun Pharmaceutical IndustriesIndia | 25 January 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-1394-9 | Sun Pharmaceutical IndustriesIndia | 25 January 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 21922-078-06 | Encube Ethicals | 26 March 2026 |
| 1 tube in 1 carton / 20 g in 1 tube | 21922-078-25 | Encube Ethicals | 26 March 2026 |
| 1 tube in 1 carton / 20 g in 1 tube | 0378-8083-20 | Mylan Pharmaceuticals | 12 July 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 0378-8083-45 | Mylan Pharmaceuticals | 17 December 2018 |
| 1 tube in 1 carton / 20 g in 1 tube | 62032-412-20 | Obagi Cosmeceuticals | 19 July 1974 |
| 1 tube in 1 carton / 20 g in 1 tube | 0574-2205-20 | Padagis | 5 May 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 0574-2205-45 | Padagis | 26 April 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 50090-3058-0 | A-S Medication Solutions | 15 June 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 50090-6819-0 | A-S Medication Solutions | 14 November 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 72162-2158-2 | Bryant Ranch Prepack | 7 December 2023 |
| 1 tube in 1 carton / 20 g in 1 tube | 16714-249-01 | Northstar RX | 25 February 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 16714-249-02 | Northstar RX | 25 February 2022 |
| 1 tube in 1 carton / 20 g in 1 tube | 68071-3865-2 | NuCare Pharmaceuticals,Inc | 10 June 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 0.05% cream.
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 0.05% 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.