roflumilast
- Product NDC
- 64380-786
- 11-digit product format
- 643800786
- Labeler code
- 64380
- Product ID
- 64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROFLUMILAST
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA208247
- Marketing category
- ANDA
- Marketing start
- 2022-10-13
- Substance
- ROFLUMILAST
- Active strength
- 500 ug/1
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- roflumilast
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROFLUMILAST | 500 ug/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-786-01 | roflumilast | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 64380-786-05 | roflumilast | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-786 | ROFLUMILAST TABLET [STRIDES PHARMA SCIENCE LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230322_78d2644d-b62c-48f5-8407-2adf09bcb144.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-786-01 | 64380078601 | 30 TABLET in 1 BOTTLE (64380-786-01) | 30 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |
| 64380-786-05 | 64380078605 | 90 TABLET in 1 BOTTLE (64380-786-05) | 90 tablet | 2022-10-13 | 0000-00-00 | No | No | Current |