ROFLUMILAST
- Product NDC
- 72162-2385
- 11-digit product format
- 721622385
- Labeler code
- 72162
- Product ID
- 72162-2385_f086d8f9-3cf8-4196-a422-c4117bd1fcaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208180
- Marketing category
- ANDA
- Marketing start
- 2022-10-19
- 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 |
|---|
| 72162-2385-3 | ROFLUMILAST | 30 in 1 BOTTLE | TABLET | 30 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2385 | ROFLUMILAST TABLET [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20240816_fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72.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 |
|---|
| 72162-2385-3 | 72162238503 | 30 TABLET in 1 BOTTLE (72162-2385-3) | 30 tablet | 2024-08-15 | No | No | Current |