Ofev
- Product NDC
- 0597-0143
- 11-digit product format
- 005970143
- Labeler code
- 0597
- Product ID
- 0597-0143_5c860918-0d7e-4aaf-b103-85f66e9dcdbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nintedanib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA205832
- Marketing category
- NDA
- Marketing start
- 2014-10-15
- Substance
- NINTEDANIB ESYLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ofev
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NINTEDANIB ESYLATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 42F62RTZ4G |
| Rxcui | 1592742, 1592748, 1592750, 1592752 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0143-60 | Ofev | 1 in 1 CARTON | CAPSULE | 1 | | 21 |
| 0597-0143-60 | Ofev | 60 in 1 BOTTLE | CAPSULE | 60 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0143 | OFEV (NINTEDANIB) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250523_da1c9f37-779e-4682-816f-93d0faa4cfc9.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 |
|---|
| 0597-0143-60 | 00597014360 | 1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE | 1 bottle | 2014-10-17 | 0000-00-00 | No | No | Current |