Prescription drug · ANDA
Nilotinib NDC 43598-055
Nilotinib hydrochloride monohydrate 50 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-055-04 | 43598005504 | 120 CAPSULE in 1 BOTTLE (43598-055-04)Marketed from Nov 19, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nilotinib
- Generic name (nonproprietary)
- nilotinib
- Active ingredients
- Nilotinib hydrochloride monohydrate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218350
- Marketing start
- Listing expires
- Other FDA classes
- Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-055_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5SPL ID 0e4d3a09-2813-d066-3d1b-2a7e0b196fd5SPL set ID 805cc504-60bb-7743-5ada-679eb3badc7fRxCUI 746606, 997653, 2002717UNII 5JHU0N1R6K
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443598005504followed by a unit qualifier and the quantityPackage 43598-0055-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Nilotinib is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult Patients With Newly Diagnosed Ph+ CML-CP Nilotinib capsules are indicated for the treatment of adult and pediatric patients greater than …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218350
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.