Roflumilast
- Product NDC
- 0904-7483
- 11-digit product format
- 009047483
- Labeler code
- 0904
- Product ID
- 0904-7483_afaf51f3-1276-4631-b549-ceb1a21aa925
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA208256
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7483-03 | Roflumilast | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 0904-7483-89 | Roflumilast | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7483 | ROFLUMILAST TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20240927_ca22f3e0-6f33-4f1c-97e5-0c962891067a.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 |
|---|
| 0904-7483-03 | 00904748303 | 30 TABLET in 1 BOTTLE (0904-7483-03) | 30 tablet | 2024-05-22 | No | No | Current |
| 0904-7483-89 | 00904748389 | 90 TABLET in 1 BOTTLE (0904-7483-89) | 90 tablet | 2024-05-22 | No | No | Current |