nilotinib
- Product NDC
- 72205-237
- 11-digit product format
- 722050237
- Labeler code
- 72205
- Product ID
- 72205-237_13b46e09-62d2-4ce9-b3c0-deafcb1f1842
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nilotinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA218544
- Marketing category
- ANDA
- Marketing start
- 2025-11-19
- 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 |
|---|
| 72205-237-92 | nilotinib | 120 in 1 BOTTLE | CAPSULE | 120 | | 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 |
|---|
| 72205-237-92 | 72205023792 | 120 CAPSULE in 1 BOTTLE (72205-237-92) | 120 capsule | 2025-11-20 | No | No | Current |