Acitretin
- Product NDC
- 46708-742
- 11-digit product format
- 467080742
- Labeler code
- 46708
- Product ID
- 46708-742_77011f2b-a2e7-4a43-9ff3-29d73f322319
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acitretin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA217774
- Marketing category
- ANDA
- Marketing start
- 2024-08-08
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-742-30 | Acitretin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-742 | ACITRETIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 1 package rows | 20240810_77011f2b-a2e7-4a43-9ff3-29d73f322319.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 |
|---|
| 46708-742-30 | 46708074230 | 30 CAPSULE in 1 BOTTLE (46708-742-30) | 30 capsule | 2024-08-08 | No | No | Current |