Nilotinib
- Product NDC
- 31722-779
- 11-digit product format
- 317220779
- Labeler code
- 31722
- Product ID
- 31722-779_44065ee4-1b6c-f3ef-e063-6394a90a797a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nilotinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA209651
- Marketing category
- ANDA
- Marketing start
- 2025-11-19
- Substance
- NILOTINIB
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F41401512X |
| Rxcui | 746606, 997653 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-779-33 | Nilotinib | 28 in 1 BLISTER PACK | CAPSULE | 28 | | 3 |
| 31722-779-33 | Nilotinib | 4 in 1 CARTON | CAPSULE | 4 | | 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 |
|---|
| 31722-779-33 | 31722077933 | 4 BLISTER PACK in 1 CARTON (31722-779-33) / 28 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2025-11-19 | No | No | Current |