Acitretin
- Product NDC
- 0378-7023
- 11-digit product format
- 003787023
- Labeler code
- 0378
- Product ID
- 0378-7023_4e629ef9-879a-443d-9397-c47962855dd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acitretin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202148
- Marketing category
- ANDA
- Marketing start
- 2016-03-10
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7023-93 | Acitretin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7023 | ACITRETIN CAPSULE [MYLAN PHARMACEUTICALS INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20240120_2150bb0f-551b-4059-a97b-187d3ab22519.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 |
|---|
| 0378-7023-93 | 00378702393 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93) | 30 capsule | 2016-03-10 | 0000-00-00 | No | No | Current |