Roflumilast
- Product NDC
- 31722-623
- 11-digit product format
- 317220623
- Labeler code
- 31722
- Product ID
- 31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA208213
- Marketing category
- ANDA
- Marketing start
- 2022-10-15
- 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 |
|---|
| 31722-623-30 | Roflumilast | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 31722-623-31 | Roflumilast | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 31722-623-32 | Roflumilast | 100 in 1 CARTON | TABLET | 100 | | 2 |
| 31722-623-90 | Roflumilast | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-623 | ROFLUMILAST (ROFLUMILAST) TABLET [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230429_f25a0230-3cf6-4366-bebe-0ea5ff8de5ab.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 |
|---|
| 31722-623-30 | 31722062330 | 30 TABLET in 1 BOTTLE (31722-623-30) | 30 tablet | 2022-10-15 | 0000-00-00 | No | No | Current |
| 31722-623-31 | 31722062331 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 31722-623-32 | 31722062332 | 100 BLISTER PACK in 1 CARTON (31722-623-32) / 10 TABLET in 1 BLISTER PACK (31722-623-31) | 100 blister pack | 2022-10-15 | 0000-00-00 | No | No | Current |
| 31722-623-90 | 31722062390 | 90 TABLET in 1 BOTTLE (31722-623-90) | 90 tablet | 2022-10-15 | 0000-00-00 | No | No | Current |