Nilotinib
- Product NDC
- 60505-3803
- 11-digit product format
- 605053803
- Labeler code
- 60505
- Product ID
- 60505-3803_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nilotinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA203640
- Marketing category
- ANDA
- Marketing start
- 2025-05-23
- Substance
- NILOTINIB
- Active strength
- 50 mg/1
- Pharmacologic classes
- Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 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
- Nilotinib
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NILOTINIB | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F41401512X |
| Rxcui | 746606, 997653, 2002717 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-3803-7 | Nilotinib | 120 in 1 BOTTLE | CAPSULE | 120 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-3803 | NILOTINIB CAPSULE [APOTEX CORP.] | 4 | Current NDC, 1 package rows | 20250525_8283672c-619f-fe60-3d25-040f95ac1440.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-3803-7 | 60505380307 | 120 CAPSULE in 1 BOTTLE (60505-3803-7) | 120 capsule | 2025-05-23 | No | No | Historical |