Prescription drug · ANDA
nilotinib NDC 73190-033
Nilotinib 150 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-033-11 | 7319000331173190003311 | 28 CAPSULE in 1 BLISTER PACK (73190-033-11)Marketed from Mar 2, 2026 | |
| 73190-033-12 | 7319000331273190003312 | 4 BLISTER PACK in 1 CARTON (73190-033-12) / 28 CAPSULE in 1 BLISTER PACKMarketed from Mar 2, 2026 |
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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARENDC labeler code 73190
- 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 73190-033_4c0bc87a-7a6c-af1e-e063-6394a90a5495SPL ID 4c0bc87a-7a6c-af1e-e063-6394a90a5495SPL set ID 4c0bc799-ce6a-822a-e063-6394a90ab748RxCUI 746606, 997653UNII F41401512X
- 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
N473190003311followed by a unit qualifier and the quantityPackage 73190-0033-11. 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.
About NDC 73190-033
- What is NDC 73190-033?
- 73190-033 is the product NDC for nilotinib, Nilotinib 150 mg/1 capsule, listed with the FDA by AvKARE. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nilotinib.
- What is the active ingredient?
- Nilotinib.
- Who is the labeler?
- AvKARE, NDC labeler code 73190. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for nilotinib?
- 17 other product NDCs are listed under this name. See all nilotinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other nilotinib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nilotinib | Nilotinib 200 mg/1 | CapsuleOral | AvKARE | 73190-034 | 73190-0034-1173190-0034-12 |
| nilotinib | Nilotinib hydrochloride monohydrate 150 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-710 | 13668-0710-5713668-0710-91 |
| nilotinib | Nilotinib hydrochloride monohydrate 200 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-711 | 13668-0711-5713668-0711-91 |
| Nilotinib | Nilotinib 150 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-779 | 31722-0779-33 |
| Nilotinib | Nilotinib 200 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-780 | 31722-0780-33 |
| Nilotinib | Nilotinib hydrochloride monohydrate 50 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc | 43598-055 | 43598-0055-04 |
| Nilotinib | Nilotinib hydrochloride monohydrate 150 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc | 43598-455 | 43598-0455-46 |
| Nilotinib | Nilotinib hydrochloride monohydrate 200 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc | 43598-456 | 43598-0456-46 |
| nilotinib | Nilotinib 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-237 | 72205-0237-92 |
| nilotinib | Nilotinib 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-238 | 72205-0238-6372205-0238-64 |
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 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-237 |
| nilotinib | Nilotinib 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-238 |
| nilotinib | Nilotinib 200 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-239 |
| nilotinib | Nilotinib 200 mg/1 | CapsuleOral | AvKARE | 73190-034 |