Home NDC 42291-939 Pazopanib
Product NDC 42291-939
11-digit product format 422910939
Labeler code 42291
Product ID 42291-939_48c0ee87-f725-1a71-e063-6394a90a72d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pazopanib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA217517
Marketing category ANDA
Marketing start 2024-04-23
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 2027-12-31
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 A217517-001 PAZOPANIB HYDROCHLORIDE PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217517-001 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 A217517-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 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 A217517-001 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Pazopanib
Listing expiration 2027-12-31 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 42291-939-12 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 42291-939 PAZOPANIB TABLET, FILM COATED [AVKARE] 1 Current NDC, 1 package rows 20240425_16c5df52-0031-034d-e063-6294a90a1717.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-939-12 42291093912 120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12) 2024-04-23 No No Current