Pazopanib

Product NDC
0480-4184
11-digit product format
004804184
Labeler code
0480
Product ID
0480-4184_048bbf33-5176-40b9-a6ed-ee377d7d078b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pazopanib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA217517
Marketing category
ANDA
Marketing start
2023-10-20
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
Pazopanib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAZOPANIB HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33Y9ANM545
Rxcui867502

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
0480-4184-89Pazopanib120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-4184PAZOPANIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]3Current NDC, 1 package rows20240601_9f7ea520-a152-401e-b1f7-b5ef8c7a2239.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSN9f7ea520-a152-401e-b1f7-b5ef8c7a22393
867502pazopanib 200 MG Oral TabletSCD9f7ea520-a152-401e-b1f7-b5ef8c7a22393
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY9f7ea520-a152-401e-b1f7-b5ef8c7a22393
867502PAZOPanib 200 MG Oral TabletPSN16c5df52-0031-034d-e063-6294a90a17172
867502pazopanib 200 MG Oral TabletSCD16c5df52-0031-034d-e063-6294a90a17172
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY16c5df52-0031-034d-e063-6294a90a17172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-4184-8900480418489120 TABLET, FILM COATED in 1 BOTTLE (0480-4184-89) 2023-10-20NoNoHistorical