Isotretinoin
- Product NDC
- 69238-1259
- 11-digit product format
- 692381259
- Labeler code
- 69238
- Product ID
- 69238-1259_831e90e7-4cd9-44e1-8f94-b136bcba2b5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216097
- Marketing category
- ANDA
- Marketing start
- 2025-10-10
- Substance
- ISOTRETINOIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| EH28UP18IF | ISOTRETINOIN | 4759-48-2 | ISOTRETINOIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-1259-3 | 69238125903 | 3 BLISTER PACK in 1 BOX (69238-1259-3) / 10 CAPSULE in 1 BLISTER PACK (69238-1259-4) | 3 blister pack | 2025-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isotretinoin | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | 2023-08-24 | HUMAN PRESCRIPTION DRUG LABEL | 9 |