Roflumilast
- Product NDC
- 68382-624
- 11-digit product format
- 683820624
- Labeler code
- 68382
- Product ID
- 68382-624_70642eb6-1ced-4f90-85b2-7d4238c197d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA208303
- Marketing category
- ANDA
- Marketing start
- 2023-05-18
- 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 |
|---|
| 68382-624-31 | 68382062431 | 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-05-18 | No | No | Historical |
| 68382-624-83 | 68382062483 | 2 BLISTER PACK in 1 CARTON (68382-624-83) / 10 TABLET in 1 BLISTER PACK (68382-624-30) | 2 blister pack | 2023-05-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Roflumilast | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2024-08-16 | HUMAN PRESCRIPTION DRUG LABEL | 3 |