Roflumilast
- Product NDC
- 0904-7493
- 11-digit product format
- 009047493
- Labeler code
- 0904
- Product ID
- 0904-7493_44dcecac-a91b-4149-b030-d44e925bee4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- ANDA208256
- Marketing category
- ANDA
- Marketing start
- 2025-10-27
- Substance
- ROFLUMILAST
- Active strength
- 250 ug/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Roflumilast
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROFLUMILAST | 250 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0P6C6ZOP5U |
| Rxcui | 1091839, 2001319 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7493-71 | Roflumilast | 28 in 1 BOTTLE | TABLET | 28 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7493-71 | 00904749371 | 28 TABLET in 1 BOTTLE (0904-7493-71) | 28 tablet | 2025-10-27 | No | No | Current |