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

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 Identifiers#

Field, Values table
FieldValues
Unii33Y9ANM545
Rxcui867502, 867506

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