Nintedanib
- Product NDC
- 60505-4818
- 11-digit product format
- 605054818
- Labeler code
- 60505
- Product ID
- 60505-4818_5fbe2775-85bd-4ab4-1552-8bff1f050dc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nintedanib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA219227
- Marketing category
- ANDA
- Marketing start
- 2026-04-02
- Substance
- NINTEDANIB ESYLATE
- Active strength
- 100 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 | 100 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 |
|---|
| 60505-4818-6 | Nintedanib | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 60505-4818-6 | Nintedanib | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4818-6 | 60505481806 | 1 BOTTLE in 1 CARTON (60505-4818-6) / 60 CAPSULE in 1 BOTTLE | 1 bottle | 2026-04-02 | No | No | Historical |