Home NDC 0078-1077 VOTRIENT
Product NDC 0078-1077
11-digit product format 000781077
Labeler code 0078
Product ID 0078-1077_026e2548-8de0-4776-9802-dd3fff2c2635
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pazopanib hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA022465
Marketing category NDA
Marketing start 2016-07-12
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022465-001 VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 N022465-002 VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022465-001 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.
Product history page 1 of 3 · 84 observed 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 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL RLD 2009-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL RLD 2009-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 VOTRIENT EQ 400MG BASE TABLET / ORAL 2009-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL RLD, RS 2009-10-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022465-001 7105530 2023-10-19 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022465-002 7105530 2023-10-19 Drug substance, Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022465-001 7105530 2023-10-19 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022465-002 7105530 2023-10-19 Drug substance, Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 7262203 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 8114885 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-001 7105530 2023-10-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 7262203 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 8114885 2021-12-19 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022465-002 7105530 2023-10-19 Drug substance, Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022465-001 7262203 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-001 8114885 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-001 7105530 2023-10-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 7262203 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 8114885 2021-12-19 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022465-002 7105530 2023-10-19 Drug substance, Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022465-001 7262203 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-001 8114885 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-001 7105530 2023-10-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 7262203 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 8114885 2021-12-19 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022465-002 7105530 2023-10-19 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022465-001 7262203 2021-12-19 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022465-001 8114885 2021-12-19 Drug substance, Drug product c0c555d07b60…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VOTRIENT
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 867502 Internal RxNorm lookup 867506 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 0078-1077-66 VOTRIENT 120 in 1 BOTTLE TABLET, FILM COATED 120 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1077 VOTRIENT (PAZOPANIB HYDROCHLORIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 14 Current NDC, Legacy NDC, 1 package rows 20250105_eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7.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 VOTRIENT PAZOPANIB HYDROCHLORIDE Novartis Pharmaceuticals Corporation eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022465 application number: NDA022465 ndc (product): 0078-1077
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-1077-66 00078107766 120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66) 2021-12-13 0000-00-00 No No Current