Prescription drug · ANDA
nilotinib NDC 72205-237
Nilotinib 50 mg/1 · Capsule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-237-92 | 72205023792 | 120 CAPSULE in 1 BOTTLE (72205-237-92)Marketed from Nov 20, 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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218544
- 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 72205-237_13b46e09-62d2-4ce9-b3c0-deafcb1f1842SPL ID 13b46e09-62d2-4ce9-b3c0-deafcb1f1842SPL set ID 13b46e09-62d2-4ce9-b3c0-deafcb1f1842RxCUI 746606, 997653, 2002717UNII F41401512XUPC 0372205237926, 0372205239630, 0372205238640, 0372205239647
- 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
N472205023792followed by a unit qualifier and the quantityPackage 72205-0237-92. 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 capsules are 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 and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Nilotinib capsules are indicated for the treatment of adult and pediatric …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218544
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| nilotinib | Nilotinib 200 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-239 |
| nilotinib | Nilotinib 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-238 |
| nilotinib | Nilotinib 150 mg/1 | CapsuleOral | AvKARE | 73190-033 |
| nilotinib | Nilotinib 200 mg/1 | CapsuleOral | AvKARE | 73190-034 |