ROFLUMILAST
- Product NDC
- 59651-801
- 11-digit product format
- 596510801
- Labeler code
- 59651
- Product ID
- 59651-801_586e58c7-172f-4c3f-a91f-045ea4d089fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213298
- Marketing category
- ANDA
- Marketing start
- 2025-01-31
- Substance
- ROFLUMILAST
- Active strength
- 250 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0P6C6ZOP5U | ROFLUMILAST | 162401-32-3 | ROFLUMILAST |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-801-20 | 59651080120 | 1 BLISTER PACK in 1 CARTON (59651-801-20) / 20 TABLET in 1 BLISTER PACK | 1 blister pack | 2025-01-31 | No | No | Historical |
| 59651-801-28 | 59651080128 | 1 BLISTER PACK in 1 CARTON (59651-801-28) / 28 TABLET in 1 BLISTER PACK | 1 blister pack | 2025-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ROFLUMILAST | Aurobindo Pharma Limited | 2025-05-27 | Human Prescription Drug Label | 6 |