Nintedanib
- Product NDC
- 69097-639
- 11-digit product format
- 690970639
- Labeler code
- 69097
- Product ID
- 69097-639_128511d3-f076-4a68-993b-53ad52233ee2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nintedanib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA212609
- Marketing category
- ANDA
- Marketing start
- 2026-04-02
- Substance
- NINTEDANIB ESYLATE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase 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
- Nintedanib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NINTEDANIB ESYLATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 42F62RTZ4G |
| Rxcui | 1592742, 1592750 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-639-03 | Nintedanib | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69097-639-03 | 69097063903 | 60 CAPSULE in 1 BOTTLE (69097-639-03) | 60 capsule | 2026-04-02 | No | No | Historical |