FDA.reportPublic FDA data

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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022465-001VOTRIENTPAZOPANIB HYDROCHLORIDEEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19
N022465-002VOTRIENTPAZOPANIB HYDROCHLORIDEEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022465-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022465-001VOTRIENTEQ 200MG BASETABLET / ORALABRLD, RS2009-10-19a50c72e98297…
2026-08-01 22:54:322026-06N022465-002VOTRIENTEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-10-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022465-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VOTRIENTPAZOPANIB HYDROCHLORIDENovartis Pharmaceuticals Corporationeeaaaf38-fb86-4d9f-a19d-0f61daac2fd72025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022465
application number: NDA022465
ndc (product): 0078-1077

Additional Listing Data#

Finished product
Yes
Brand name base
VOTRIENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAZOPANIB HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33Y9ANM545Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
867502Internal RxNorm lookup
867506Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a22552f9-c212-7ece-256c-f50df49d1fe2Product name220250204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1077-66VOTRIENT120 in 1 BOTTLETABLET, FILM COATED12015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1077-66EA - Each0078-1077b5074e0f-bdcf-40cb-b2a4-d88c1bbeae5312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1077VOTRIENT (PAZOPANIB HYDROCHLORIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]14Current NDC, Legacy NDC, 1 package rows20250105_eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSNeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715
867506Votrient 200 MG Oral TabletPSNeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715
867506pazopanib 200 MG Oral Tablet [Votrient]SBDeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715
867502pazopanib 200 MG Oral TabletSCDeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSYeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715
867506Votrient 200 MG Oral TabletSYeeaaaf38-fb86-4d9f-a19d-0f61daac2fd715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-1077-6600078107766120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66) 2021-12-130000-00-00NoNoCurrent