pazopanib

Generic: pazopanib

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pazopanib
Generic Name pazopanib
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pazopanib hydrochloride 200 mg/1

Manufacturer
SUN PHARMACEUTICAL INDUSTRIES, INC.

Identifiers & Regulatory

Product NDC 63304-116
Product ID 63304-116_893f0d84-70b8-41c6-bc13-19031fb43669
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215837
Listing Expiration 2026-12-31
Marketing Start 2023-10-20

Pharmacologic Class

Classes
cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304116
Hyphenated Format 63304-116

Supplemental Identifiers

RxCUI
867502
UNII
33Y9ANM545

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pazopanib (source: ndc)
Generic Name pazopanib (source: ndc)
Application Number ANDA215837 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30)
source: ndc

Packages (2)

63304-116-13 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13) 63304-116-30 30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30)

Ingredients (1)

pazopanib hydrochloride (200 mg/1)

Linked Drug Pages (1)

Pazopanib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "893f0d84-70b8-41c6-bc13-19031fb43669", "openfda": {"unii": ["33Y9ANM545"], "rxcui": ["867502"], "spl_set_id": ["d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5"], "manufacturer_name": ["SUN PHARMACEUTICAL INDUSTRIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13)", "package_ndc": "63304-116-13", "marketing_start_date": "20231020"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30)", "package_ndc": "63304-116-30", "marketing_start_date": "20231020"}], "brand_name": "Pazopanib", "product_id": "63304-116_893f0d84-70b8-41c6-bc13-19031fb43669", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "63304-116", "generic_name": "Pazopanib", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pazopanib", "active_ingredients": [{"name": "PAZOPANIB HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA215837", "marketing_category": "ANDA", "marketing_start_date": "20231020", "listing_expiration_date": "20261231"}