Home NDC 63304-116 Pazopanib
Product NDC 63304-116
11-digit product format 633040116
Labeler code 63304
Product ID 63304-116_893f0d84-70b8-41c6-bc13-19031fb43669
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pazopanib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SUN PHARMACEUTICAL INDUSTRIES, INC.
Application ANDA215837
Marketing category ANDA
Marketing start 2023-10-20
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 43 .
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 A215837-001 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 A215837-001 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 2026-09-14 22:38:34 2026-08 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215837-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 63304-116-13 Pazopanib 120 in 1 BOTTLE TABLET, FILM COATED 120 4 63304-116-30 Pazopanib 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-116 PAZOPANIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 Current NDC, 2 package rows 20240221_d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5.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 SUN PHARMACEUTICAL INDUSTRIES, INC. d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5 2026-05-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215837 application number: ANDA215837 ndc (product): 63304-116
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63304-116-13 63304011613 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13) 2023-10-20 No No Current 63304-116-30 63304011630 30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30) 2023-10-20 No No Current