Isotretinoin
- Product NDC
- 70710-1576
- 11-digit product format
- 707101576
- Labeler code
- 70710
- Product ID
- 70710-1576_a5b78223-8bce-490b-a83c-e342c25c082a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA216633
- Marketing category
- ANDA
- Marketing start
- 2025-06-09
- Substance
- ISOTRETINOIN
- Active strength
- 25 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 70710-1576_a5b78223-8bce-490b-a83c-e342c25c082a
- SPL ID
- a5b78223-8bce-490b-a83c-e342c25c082a
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Isotretinoin
- Generic name
- Isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2025-06-09
- Marketing category
- ANDA
- Application number
- ANDA216633
- Pharmacologic classes
- Retinoid [EPC]; Retinoids [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ISOTRETINOIN | 25 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930, 1547561, 1547565 |
| Spl Set Id | 31f62a49-4c6d-4ce3-a0ca-d159562370b1 |
| Manufacturer Name | Zydus Pharmaceuticals USA Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 70710-1576-8 | 3 BLISTER PACK in 1 CARTON (70710-1576-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1576-2) | 2025-06-09 | No |
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 |
|---|
| 70710-1576-8 | 70710157608 | 3 BLISTER PACK in 1 CARTON (70710-1576-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1576-2) | 3 blister pack | 2025-06-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isotretinoin | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-05-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |