ROFLUMILAST
- Product NDC
- 72162-2385
- 11-digit product format
- 721622385
- Labeler code
- 72162
- Product ID
- 72162-2385_f086d8f9-3cf8-4196-a422-c4117bd1fcaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208180
- Marketing category
- ANDA
- Marketing start
- 2022-10-19
- 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
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 |
|---|
| 72162-2385-3 | 72162238503 | 30 TABLET in 1 BOTTLE (72162-2385-3) | 30 tablet | 2024-08-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ROFLUMILAST | Bryant Ranch Prepack | 2024-08-15 | HUMAN PRESCRIPTION DRUG LABEL | 100 |