pazopanib

Generic: pazopanib hydrochloride

Labeler: novugen pharma (usa) llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pazopanib
Generic Name pazopanib hydrochloride
Labeler novugen pharma (usa) llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pazopanib hydrochloride 200 mg/1

Manufacturer
Novugen Pharma (USA) LLC.

Identifiers & Regulatory

Product NDC 82293-022
Product ID 82293-022_2007980f-ffca-6d8f-e063-6294a90ae3ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218231
Listing Expiration 2026-12-31
Marketing Start 2024-04-24

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 82293022
Hyphenated Format 82293-022

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 hydrochloride (source: ndc)
Application Number ANDA218231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10)
source: ndc

Packages (1)

82293-022-10 120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10)

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": "2007980f-ffca-6d8f-e063-6294a90ae3ff", "openfda": {"unii": ["33Y9ANM545"], "rxcui": ["867502"], "spl_set_id": ["25305d33-caa0-4577-8b7b-06e430c34c39"], "manufacturer_name": ["Novugen Pharma (USA) LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10)", "package_ndc": "82293-022-10", "marketing_start_date": "20240424"}], "brand_name": "pazopanib", "product_id": "82293-022_2007980f-ffca-6d8f-e063-6294a90ae3ff", "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": "82293-022", "generic_name": "pazopanib hydrochloride", "labeler_name": "Novugen Pharma (USA) LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pazopanib", "active_ingredients": [{"name": "PAZOPANIB HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA218231", "marketing_category": "ANDA", "marketing_start_date": "20240424", "listing_expiration_date": "20261231"}