Quick answers
- What is Accutane?
- Accutane is a brand name of Isotretinoin, a prescription medicine. The FDA NDC Directory lists 4 Accutane products in 4 strengths and forms.
- Who makes Accutane?
- Dr Reddys Labs Ltd holds the FDA application for Accutane (ANDA202099, approved March 25, 2013).
- Is there a generic or store brand of Accutane?
- Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Accutane product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Accutane been recalled?
- No recall linked to Accutane products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Accutane is
Each Accutane product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Isotretinoin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| isotretinoin 10 mg capsule, gelatin coated (oral) | Accutane | 2 products, 2 companies | DailyMed |
| isotretinoin 20 mg capsule, gelatin coated (oral) | Accutane | 2 products, 2 companies | DailyMed |
| isotretinoin 30 mg capsule, gelatin coated (oral) | Accutane | 2 products, 2 companies | DailyMed |
| isotretinoin 40 mg capsule, gelatin coated (oral) | Accutane | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Isotretinoin →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA202099 | Dr Reddys Labs Ltd | March 25, 2013 | 4 |
Companies that list Accutane
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Accutane products.
- JG Pharma Inc.4 products
Recalls
No recall linked to Accutane products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.