Roflumilast
- Product NDC
- 0378-1905
- 11-digit product format
- 003781905
- Labeler code
- 0378
- Product ID
- 0378-1905_60c7587f-e0db-41b8-94e2-67da4544c997
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Roflumilast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208257
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1905 | ROFLUMILAST TABLET [MYLAN PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20250104_0a917c07-edeb-44f0-a26c-8161166dc30b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1905-77 | 00378190577 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-1905-77) | 90 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |
| 0378-1905-93 | 00378190593 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-1905-93) | 30 tablet | 2022-10-19 | 0000-00-00 | No | No | Current |