Medicine
Acitretin 25 mg capsule
Acitretin 25 mg capsule is a generic prescription medicine for oral use, made by 7 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). See USP Controlled Room Temperature. Protect…
Key facts
- Active ingredient (INN)
- Acitretin
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules and 5 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAmneal Pharmaceuticals of New YorkAvKAREBryant Ranch PrepackMylan PharmaceuticalsSigmapharm LaboratoriesTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 to 25°C (68 to 77°F). See USP Controlled Room Temperature. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D05BB02 Acitretin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 July 2013
- Identifiers
- RxCUI 199690, 199689, 894859 +1DailyMed set ID 1e87e415-070d-41f5-9d93-17793e8ad8a6, a6546625-acb8-460e-b34e-f795bfb3680a, 993a5325-cd10-4450-b5ea-1c0a90510df6 +5NDC 72162-2223, 42794-083, 0093-1136 +5Application ANDA204633, ANDA091455, ANDA202552 +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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 46708-743-30 | Alembic PharmaceuticalsIndia | 8 August 2024 |
| 30 capsule in 1 bottle | 62332-743-30 | Alembic PharmaceuticalsIndia | 8 August 2024 |
| 30 capsule in 1 bottle, plastic | 0115-1753-08 | Amneal Pharmaceuticals of New York | 4 January 2016 |
| 30 capsule in 1 bottle, plastic | 0378-7023-93 | Mylan Pharmaceuticals | 10 March 2016 |
| 30 capsule in 1 bottle | 42794-083-08 | Sigmapharm Laboratories | 16 September 2015 |
| 30 capsule in 1 bottle | 0093-1136-56 | Teva Pharmaceuticals | 19 July 2013 |
| 30 capsule in 1 bottle | 42291-088-30 | AvKARE | 11 October 2017 |
| 30 capsule in 1 bottle | 72162-2223-3 | Bryant Ranch Prepack | 26 January 2024 |
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 28 October 1996 | 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
Other strengths and forms of Acitretin
Clinical summary
Acitretin is a retinoid indicated for the treatment of severe psoriasis in adults. It is available as capsules for oral use. MedsAcross supplies Acitretin 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 AcitretinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ACITRETIN prescribing information (Sigmapharm Laboratories) · U.S. National Library of Medicine, DailyMed
Need Acitretin 25 mg capsule 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.