Nilotinib
- Product NDC
- 43598-456
- 11-digit product format
- 435980456
- Labeler code
- 43598
- Product ID
- 43598-456_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nilotinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc
- Application
- ANDA218350
- Marketing category
- ANDA
- Marketing start
- 2025-11-19
- Substance
- NILOTINIB HYDROCHLORIDE MONOHYDRATE
- Active strength
- 200 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 HYDROCHLORIDE MONOHYDRATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5JHU0N1R6K |
| Rxcui | 746606, 997653, 2002717 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-456-46 | Nilotinib | 8 in 1 CARTON | CAPSULE | 8 | | 9 |
| 43598-456-74 | Nilotinib | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-456-46 | 43598045646 | 8 BLISTER PACK in 1 CARTON (43598-456-46) / 14 CAPSULE in 1 BLISTER PACK (43598-456-74) | 8 blister pack | 2025-11-19 | No | No | Current |
| 43598-456-74 | 43598045674 | 14 in 1 BLISTER PACK | | | | | Historical |