ISOTRETINOIN
- Product NDC
- 59651-634
- 11-digit product format
- 596510634
- Labeler code
- 59651
- Product ID
- 59651-634_b861fc3d-a8b7-473f-bca1-b0e6269a0683
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOTRETINOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA218194
- Marketing category
- ANDA
- Marketing start
- 2024-01-29
- Substance
- ISOTRETINOIN
- Active strength
- 30 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 | 30 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 |
|---|
| 59651-634-03 | ISOTRETINOIN | 3 in 1 CARTON | CAPSULE | 3 | | 3 |
| 59651-634-03 | ISOTRETINOIN | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-634 | ISOTRETINOIN CAPSULE [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20241103_4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-634-03 | 59651063403 | 3 BLISTER PACK in 1 CARTON (59651-634-03) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2024-01-29 | No | No | Historical |