Roflumilast
- Product NDC
- 70771-1674
- 11-digit product format
- 707711674
- Labeler code
- 70771
- Product ID
- 70771-1674_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA208303
- Marketing category
- ANDA
- Marketing start
- 2022-10-03
- 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 |
|---|
| 70771-1674-3 | Roflumilast | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 70771-1674-9 | 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 |
|---|
| 70771-1674 | ROFLUMILAST TABLET [ZYDUS LIFESCIENCES LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240815_e87287bd-eae3-46c3-9072-04800aeabf40.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 |
|---|
| 70771-1674-3 | 70771167403 | 30 TABLET in 1 BOTTLE (70771-1674-3) | 30 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |
| 70771-1674-9 | 70771167409 | 90 TABLET in 1 BOTTLE (70771-1674-9) | 90 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |