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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isotretinoin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ISOTRETINOIN | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930, 1547561, 1547565 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8300c0f6-79a4-735b-88ec-d781bfffdb10 | Product name | 5 | 20260305 |
| 644afe93-ba9b-4043-8e40-a9fe9af2d5d7 | Product name | 2 | 20250616 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| e5fedfa5-6b96-4769-872b-95d1e7f3a85a | Product name | 1 | 20200415 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-1259-3 | Isotretinoin | 3 in 1 BOX | CAPSULE | 3 | 9 | |
| 69238-1259-4 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE | 10 | 9 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197843 | ISOtretinoin 10 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 197844 | ISOtretinoin 20 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 1547561 | ISOtretinoin 25 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 403930 | ISOtretinoin 30 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 1547565 | ISOtretinoin 35 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 197845 | ISOtretinoin 40 MG Oral Capsule | PSN | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 197843 | isotretinoin 10 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 197844 | isotretinoin 20 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 1547561 | isotretinoin 25 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 403930 | isotretinoin 30 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 1547565 | isotretinoin 35 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
| 197845 | isotretinoin 40 MG Oral Capsule | SCD | 9f1c8971-c6dc-4708-848b-5cee50b6c32a | 9 |
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 | Current |
| 69238-1259-4 | 69238125904 | 10 in 1 BLISTER PACK | Historical |