Roflumilast
- Product NDC
- 51407-975
- 11-digit product format
- 514070975
- Labeler code
- 51407
- Product ID
- 51407-975_30dd6be3-6f60-c6a9-e063-6294a90afaa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA212490
- Marketing category
- ANDA
- Marketing start
- 2023-04-18
- 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 |
|---|
| 51407-975-90 | Roflumilast | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-975 | ROFLUMILAST TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | Current NDC, 1 package rows | 20250326_30dd6eae-6435-cae1-e063-6294a90a003b.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 |
|---|
| 51407-975-90 | 51407097590 | 90 TABLET in 1 BOTTLE (51407-975-90) | 90 tablet | 2025-02-13 | No | No | Historical |