Isotretinoin
- Product NDC
- 0591-2433
- 11-digit product format
- 005912433
- Labeler code
- 0591
- Product ID
- 0591-2433_2f164fd8-4912-4149-9292-0dc2249a69a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA205063
- Marketing category
- ANDA
- Marketing start
- 2021-04-29
- Substance
- ISOTRETINOIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isotretinoin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930, 1547561, 1547565 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2433-15 | Isotretinoin | 3 in 1 CARTON | CAPSULE | 3 | | 20 |
| 0591-2433-45 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2433 | ISOTRETINOIN CAPSULE [ACTAVIS PHARMA, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250524_1cf11710-f966-4529-8e08-02175f588bca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2433-15 | 00591243315 | 3 BLISTER PACK in 1 CARTON (0591-2433-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2433-45) | 3 blister pack | 2021-04-29 | 0000-00-00 | No | No | Current |
| 0591-2433-45 | 00591243345 | 10 in 1 BLISTER PACK | | | | | | Historical |