Roflumilast
- Product NDC
- 13668-476
- 11-digit product format
- 136680476
- Labeler code
- 13668
- Product ID
- 13668-476_eea14f4b-9ed6-1c0e-e053-2a95a90afb85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA208272
- Marketing category
- ANDA
- Marketing start
- 2022-10-19
- Marketing end
- 0000-00-00
- Substance
- ROFLUMILAST
- Active strength
- 500 ug/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-476-05 | 13668047605 | 500 TABLET in 1 BOTTLE (13668-476-05) | 500 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |
| 13668-476-30 | 13668047630 | 30 TABLET in 1 BOTTLE (13668-476-30) | 30 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |
| 13668-476-74 | 13668047674 | 100 TABLET in 1 CARTON (13668-476-74) | 100 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |
| 13668-476-90 | 13668047690 | 90 TABLET in 1 BOTTLE (13668-476-90) | 90 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |