Roflumilast
- Product NDC
- 0904-7399
- 11-digit product format
- 009047399
- Labeler code
- 0904
- Product ID
- 0904-7399_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
- 2023-12-26
- Substance
- ROFLUMILAST
- Active strength
- 500 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 | 500 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 |
|---|
| 0904-7399-46 | Roflumilast | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 0904-7399-89 | Roflumilast | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7399 | ROFLUMILAST TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20240612_c51b80f3-a591-4db9-81b4-b91603e35d7c.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 |
|---|
| 0904-7399-46 | 00904739946 | 30 TABLET in 1 BOTTLE (0904-7399-46) | 30 tablet | 2023-12-26 | No | No | Current |
| 0904-7399-89 | 00904739989 | 90 TABLET in 1 BOTTLE (0904-7399-89) | 90 tablet | 2023-12-26 | No | No | Current |