Medicine
Isotretinoin 25 mg capsule
Isotretinoin 25 mg capsule is a generic prescription medicine for oral 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
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Isotretinoin
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 3 blister pack and 3 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaActavis PharmaAmneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AD04 Isotretinoin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 December 2020
- Identifiers
- RxCUI 197843, 197844, 197845 +3DailyMed set ID b44200ba-6672-4ea7-b151-7caec3f53c9c, 1cf11710-f966-4529-8e08-02175f588bca, 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6 +3NDC 57664-022, 0591-2451, 59651-633 +3Application NDA021951, ANDA205063, ANDA218194 +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 |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 70710-1576-8 | Zydus LifesciencesIndia | 9 June 2025 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 70771-1664-8 | Zydus LifesciencesIndia | 9 June 2025 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 59651-633-03 | Aurobindo PharmaIndia | 29 January 2024 |
| 3 blister pack in 1 box / 10 capsule in 1 blister pack | 57664-022-97 | Sun Pharmaceutical IndustriesIndia | 29 December 2020 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 0591-2451-15 | Actavis Pharma | 29 April 2021 |
| 3 blister pack in 1 box / 10 capsule in 1 blister pack | 69238-1256-3 | Amneal Pharmaceuticals | 10 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 7 May 1982 | 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 Isotretinoin 25 mg capsule.
Other strengths and forms of Isotretinoin
Clinical summary
Isotretinoin is a retinoid indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. MedsAcross supplies Isotretinoin 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 IsotretinoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Absorica LD prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Isotretinoin 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.