ROFLUMILAST
- Product NDC
- 69292-631
- 11-digit product format
- 692920631
- Labeler code
- 69292
- Product ID
- 69292-631_c8a1a486-21dc-4e33-8e28-bb02456040ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma Inc.
- Application
- ANDA208236
- Marketing category
- ANDA
- Marketing start
- 2026-02-05
- Substance
- ROFLUMILAST
- Active strength
- 500 ug/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROFLUMILAST
- Listing expiration
- 2027-12-31
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 |
|---|
| 69292-631-30 | ROFLUMILAST | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 69292-631-90 | ROFLUMILAST | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69292-631-30 | 69292063130 | 30 TABLET in 1 BOTTLE (69292-631-30) | 30 tablet | 2026-02-05 | No | No | Historical |
| 69292-631-90 | 69292063190 | 90 TABLET in 1 BOTTLE (69292-631-90) | 90 tablet | 2026-02-05 | No | No | Historical |