Acitretin
- Product NDC
- 0115-1751
- 11-digit product format
- 001151751
- Labeler code
- 0115
- Product ID
- 0115-1751_233bc68a-a24e-4f19-8477-3a11e80e68df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acitretin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA202552
- Marketing category
- ANDA
- Marketing start
- 2016-01-04
- Substance
- ACITRETIN
- Active strength
- 17.5 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
- Acitretin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACITRETIN | 17.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LCH760E9T7 |
| Rxcui | 199689, 199690, 894859, 894863 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1751-08 | Acitretin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1751 | ACITRETIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20231231_85507f6c-f802-479e-bacc-624b5136d092.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 |
|---|
| 0115-1751-08 | 00115175108 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08) | 30 capsule | 2016-01-04 | 0000-00-00 | No | No | Current |