Prescription drug · NDA
Tasigna (Nilotinib) NDC 0078-0526
Nilotinib hydrochloride monohydrate 200 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0526-51 | 0007805265100078052651 | 28 CAPSULE in 1 BLISTER PACK (0078-0526-51)Marketed from Oct 29, 2007 | |
| 0078-0526-87 | 0007805268700078052687 | 4 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACKMarketed from Oct 29, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tasigna
- Generic name (nonproprietary)
- nilotinib
- Active ingredients
- Nilotinib hydrochloride monohydrate — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022068
- 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 0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102SPL ID fe0fef5b-4f09-4f67-946f-67e84d10e102SPL set ID 6093952a-5248-45cb-ad17-33716a411146RxCUI 746606, 746609, 997653, 1002300, 2002717, 2002719UNII 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
N400078052651followed by a unit qualifier and the quantityPackage 00078-0526-51. 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)
Tasigna 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 and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Tasigna is indicated for the treatment of adult and pediatric patients gr…
Excerpt only. Read the full label for complete information.
About NDC 0078-0526
- What is NDC 0078-0526?
- 0078-0526 is the product NDC for Tasigna (nilotinib), Nilotinib hydrochloride monohydrate 200 mg/1 capsule, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tasigna (Nilotinib).
- What is the active ingredient?
- Nilotinib hydrochloride monohydrate.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tasigna?
- 2 other product NDCs are listed under this name. See all Tasigna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tasigna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tasignanilotinib | Nilotinib hydrochloride monohydrate 150 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0592 | 00078-0592-5100078-0592-87 |
| Tasignanilotinib | Nilotinib hydrochloride monohydrate 50 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0951 | 00078-0951-66 |
Other NDCs under NDA 022068
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 |
|---|---|---|---|---|
| Tasignanilotinib | Nilotinib hydrochloride monohydrate 150 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0592 |
| Tasignanilotinib | Nilotinib hydrochloride monohydrate 50 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0951 |