Home NDC 0078-0670-66 VOTRIENT
Product NDC 0078-0670
Requested package NDC 0078-0670-66
11-digit product format 000780670
Labeler code 0078
Product ID 0078-0670_d64a4078-2cff-48a7-a621-c31d82703ae6
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
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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VOTRIENT PAZOPANIB HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19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.
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 N022465-001 VOTRIENT EQ 200MG BASE TABLET / ORAL AB RLD, RS 2009-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022465-002 VOTRIENT EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-19 a50c72e98297…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 N022465-001 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 · 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0670-66 00078067066 120 TABLET, FILM COATED in 1 BOTTLE (0078-0670-66) 2016-07-12 0000-00-00 No No Current