Home NDC 82293-022 pazopanib
Product NDC 82293-022
11-digit product format 822930022
Labeler code 82293
Product ID 82293-022_2007980f-ffca-6d8f-e063-6294a90ae3ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pazopanib hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novugen Pharma (USA) LLC.
Application ANDA218231
Marketing category ANDA
Marketing start 2024-04-24
Substance PAZOPANIB HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218231-001 PAZOPANIB HYDROCHLORIDE PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218231-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A218231-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join pazopanib PAZOPANIB HYDROCHLORIDE Novugen Pharma (USA) LLC. 25305d33-caa0-4577-8b7b-06e430c34c39 2024-08-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218231 application number: ANDA218231 ndc (product): 82293-022
Additional Listing Data#
Finished product Yes
Brand name base pazopanib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAZOPANIB HYDROCHLORIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33Y9ANM545 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 867502 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82293-022-10 pazopanib 120 in 1 BOTTLE TABLET, FILM COATED 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82293-022 PAZOPANIB (PAZOPANIB HYDROCHLORIDE) TABLET, FILM COATED [NOVUGEN PHARMA (USA) LLC.] 2 Current NDC, 1 package rows 20240820_25305d33-caa0-4577-8b7b-06e430c34c39.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82293-022-10 82293002210 120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10) 2024-04-24 No No Current