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NDC 63304-0116-13 Pazopanib 200 mg/1 Details
Pazopanib 200 mg/1
Pazopanib is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SUN PHARMACEUTICAL INDUSTRIES, INC.. The primary component is PAZOPANIB HYDROCHLORIDE.
MedlinePlus Drug Summary
Pazopanib is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) in adults. Pazopanib is in a class of medications called kinase inhibitors. It works by slowing or stopping the spread of cancer cells.
Related Packages: 63304-0116-13Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Pazopanib
Product Information
| NDC | 63304-0116 |
|---|---|
| Product ID | 63304-116_3aa752ae-7fad-4728-bded-7a3e1a4b3589 |
| Associated GPIs | |
| GCN Sequence Number | 065777 |
| GCN Sequence Number Description | pazopanib HCl TABLET 200 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 27829 |
| HICL Sequence Number | 036709 |
| HICL Sequence Number Description | PAZOPANIB HCL |
| Brand/Generic | Generic |
| Proprietary Name | Pazopanib |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pazopanib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | PAZOPANIB HYDROCHLORIDE |
| Labeler Name | SUN PHARMACEUTICAL INDUSTRIES, INC. |
| Pharmaceutical Class | Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215837 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63304-0116-13 (63304011613)
| NDC Package Code | 63304-116-13 |
|---|---|
| Billing NDC | 63304011613 |
| Package | 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13) |
| Marketing Start Date | 2023-10-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |