ROFLUMILAST
- Product NDC
- 59651-275
- 11-digit product format
- 596510275
- Labeler code
- 59651
- Product ID
- 59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213298
- Marketing category
- ANDA
- Marketing start
- 2023-04-17
- 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 |
|---|
| 59651-275-30 | ROFLUMILAST | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 59651-275-90 | ROFLUMILAST | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-275 | ROFLUMILAST TABLET [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20250529_7cb11d48-6bb9-437b-bc7f-382050a2d3e6.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 |
|---|
| 59651-275-30 | 59651027530 | 30 TABLET in 1 BOTTLE (59651-275-30) | 30 tablet | 2023-04-17 | No | No | Current |
| 59651-275-90 | 59651027590 | 90 TABLET in 1 BOTTLE (59651-275-90) | 90 tablet | 2023-04-17 | No | No | Current |