nilotinib
- Product NDC
- 73190-033
- 11-digit product format
- 731900033
- Labeler code
- 73190
- Product ID
- 73190-033_4c0bc87a-7a6c-af1e-e063-6394a90a5495
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nilotinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA218544
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nilotinib
- Listing expiration
- 2027-12-31
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 |
|---|
| 73190-033-11 | nilotinib | 28 in 1 BLISTER PACK | CAPSULE | 28 | | 1 |
| 73190-033-12 | nilotinib | 4 in 1 CARTON | CAPSULE | 4 | | 1 |
| 73190-033-12 | nilotinib | 28 in 1 BLISTER PACK | CAPSULE | 28 | | 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 |
|---|
| 73190-033-11 | 73190003311 | 28 CAPSULE in 1 BLISTER PACK (73190-033-11) | 28 capsule | 2026-03-02 | No | No | Current |
| 73190-033-12 | 73190003312 | 4 BLISTER PACK in 1 CARTON (73190-033-12) / 28 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2026-03-02 | No | No | Current |