Isotretinoin
- Product NDC
- 69238-1174
- 11-digit product format
- 692381174
- Labeler code
- 69238
- Product ID
- 69238-1174_c2645360-e4a8-4737-9065-3dbbd4b6e6b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA207792
- Marketing category
- ANDA
- Marketing start
- 2017-10-02
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1174-1 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 26 |
| 69238-1174-3 | Isotretinoin | 3 in 1 CARTON | CAPSULE, LIQUID FILLED | 3 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1174 | ISOTRETINOIN CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS NY LLC] | 26 | Current NDC, Legacy NDC, 2 package rows | 20231231_c2917c3d-3499-48a0-ba53-120cb979195d.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 |
|---|
| 69238-1174-1 | 69238117401 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 69238-1174-3 | 69238117403 | 3 BLISTER PACK in 1 CARTON (69238-1174-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1174-1) | 3 blister pack | 2017-10-02 | 0000-00-00 | No | No | Current |