Home NDC 60505-4779 Pazopanib
Product NDC 60505-4779
11-digit product format 605054779
Labeler code 60505
Product ID 60505-4779_13431d63-13a5-2a76-c6de-06799bc59e29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pazopanib
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA217713
Marketing category ANDA
Marketing start 2023-10-19
Substance PAZOPANIB
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 A217713-001 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 A217713-001 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 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217713-001 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 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217713-001 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 A217713-001 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 A217713-001 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 A217713-001 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 A217713-001 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 A217713-001 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 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217713-001 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 A217713-001 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 A217713-001 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 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217713-001 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 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217713-001 PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB 2023-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217713-001 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 A217713-001 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 A217713-001 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 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4779-5 Pazopanib 500 in 1 BOTTLE TABLET 500 4 60505-4779-7 Pazopanib 120 in 1 BOTTLE TABLET 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4779 PAZOPANIB TABLET [APOTEX CORP.] 3 Current NDC, 2 package rows 20240301_b05ea49a-a764-5ff2-6e4a-26add69da9e2.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 Golden State Medical Supply, Inc. 115eb5bb-1403-fb3d-e063-6394a90ad320 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217713 application number: ANDA217713
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4779-5 60505477905 500 TABLET in 1 BOTTLE (60505-4779-5) 500 tablet 2023-10-19 No No Current 60505-4779-7 60505477907 120 TABLET in 1 BOTTLE (60505-4779-7) 120 tablet 2023-10-19 No No Current