ACITRETIN
- Product NDC
- 42794-083
- 11-digit product format
- 427940083
- Labeler code
- 42794
- Product ID
- 42794-083_f1f1dd05-77f9-ff40-e053-2995a90a2e80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACITRETIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sigmapharm Laboratories, LLC
- Application
- ANDA204633
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- Substance
- ACITRETIN
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LCH760E9T7 |
| Rxcui | 199689, 199690, 894859 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42794-083-08 | ACITRETIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42794-083 | ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20230111_a6546625-acb8-460e-b34e-f795bfb3680a.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 |
|---|
| 42794-083-08 | 42794008308 | 30 CAPSULE in 1 BOTTLE (42794-083-08) | 30 capsule | 2015-09-16 | 0000-00-00 | No | No | Current |