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 42 .
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 2026-08-18 06:07:40 2026-07 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218231-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2024-04-23 a50c72e98297…
Observed Orange Book normalized TE history# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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