NDC 0591-2501 – Isotretinoin
Isotretinoin 35 mg/1 · Capsule · Oral
Product NDC0591-2501
Product details
- Brand name
- Isotretinoin
- Generic name
- Isotretinoin
- Labeler
- Actavis Pharma, Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA205063
- Marketed since
- April 29, 2021
- Listing expires
- December 31, 2027
- Pharmacologic class
- Retinoid
Active ingredients
- Isotretinoin 35 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0591-2501-15 | 3 BLISTER PACK in 1 CARTON (0591-2501-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2501-45) | Apr 29, 2021 |
Recalls mentioning this NDC
- D-0446-2026 Apr 15, 2026 · Class II
Superpotent and Subpotent - D-0445-2026 Apr 15, 2026 · Class II
Superpotent and Subpotent - D-0439-2024 Apr 17, 2024 · Class II
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Other Isotretinoin products
- 0591-2433 Isotretinoin 10 mg/1 · Capsule · Actavis Pharma, Inc.
- 0591-2434 Isotretinoin 20 mg/1 · Capsule · Actavis Pharma, Inc.
- 0591-2435 Isotretinoin 30 mg/1 · Capsule · Actavis Pharma, Inc.
- 0591-2436 Isotretinoin 40 mg/1 · Capsule · Actavis Pharma, Inc.
- 0591-2451 Isotretinoin 25 mg/1 · Capsule · Actavis Pharma, Inc.
- 69238-1256 Isotretinoin 25 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 69238-1257 Isotretinoin 30 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 69238-1255 Isotretinoin 20 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 69238-1259 Isotretinoin 40 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 69238-1254 Isotretinoin 10 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 69238-1258 Isotretinoin 35 mg/1 · Capsule · Amneal Pharmaceuticals NY LLC
- 84386-011 Isotretinoin 40 mg/1 · Capsule · Aurobindo Pharma Limited