Prescription drug · ANDA
Pazopanib NDC 63304-116
Pazopanib hydrochloride 200 mg/1 · Tablet, Film coated · Oral · SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-116-13 | 63304011613 | 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13)Marketed from Oct 20, 2023 | |
| 63304-116-30 | 63304011630 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30)Marketed from Oct 20, 2023 |
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)
- Pazopanib
- Generic name (nonproprietary)
- pazopanib
- Active ingredients
- Pazopanib hydrochloride — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215837
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63304-116_522bc5e6-38ab-65fd-e063-6394a90a97d6SPL ID 522bc5e6-38ab-65fd-e063-6394a90a97d6SPL set ID d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5RxCUI 867502UNII 33Y9ANM545UPC 0363304116137
- 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
N463304011613followed by a unit qualifier and the quantityPackage 63304-0116-13. 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)
Pazopanib tablets are kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). (1.1) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. (1.2) Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : Th…
Excerpt only. Read the full label for complete information.