Roflumilast
- Product NDC
- 60687-786
- 11-digit product format
- 606870786
- Labeler code
- 60687
- Product ID
- 60687-786_276fef08-9f1c-11d8-e063-6294a90af500
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA208213
- Marketing category
- ANDA
- Marketing start
- 2023-12-07
- 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 |
|---|
| 60687-786-11 | Roflumilast | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 60687-786-21 | Roflumilast | 30 in 1 CARTON | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-786 | ROFLUMILAST TABLET [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, 2 package rows | 20241123_913f1b95-9c46-40d5-a6e9-cff2e5e07eaa.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 |
|---|
| 60687-786-11 | 60687078611 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-786-21 | 60687078621 | 30 BLISTER PACK in 1 CARTON (60687-786-21) / 1 TABLET in 1 BLISTER PACK (60687-786-11) | 30 blister pack | 2023-12-07 | No | No | Historical |