FDA.reportPublic FDA data

Pazopanib

Product NDC
60505-4779
11-digit product format
605054779
Labeler code
60505
Product ID
60505-4779_13431d63-13a5-2a76-c6de-06799bc59e29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pazopanib
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA217713
Marketing category
ANDA
Marketing start
2023-10-19
Substance
PAZOPANIB
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
PAZOPANIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7RN5DR86CK
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
60505-4779-5Pazopanib500 in 1 BOTTLETABLET5004
60505-4779-7Pazopanib120 in 1 BOTTLETABLET1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4779PAZOPANIB TABLET [APOTEX CORP.]3Current NDC, 2 package rows20240301_b05ea49a-a764-5ff2-6e4a-26add69da9e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSNb05ea49a-a764-5ff2-6e4a-26add69da9e24
867502pazopanib 200 MG Oral TabletSCDb05ea49a-a764-5ff2-6e4a-26add69da9e24
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSYb05ea49a-a764-5ff2-6e4a-26add69da9e24
867502PAZOPanib 200 MG Oral TabletPSN115eb5bb-1403-fb3d-e063-6394a90ad3203
867502pazopanib 200 MG Oral TabletSCD115eb5bb-1403-fb3d-e063-6394a90ad3203
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY115eb5bb-1403-fb3d-e063-6394a90ad3203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4779-560505477905500 TABLET in 1 BOTTLE (60505-4779-5) 500 tablet2023-10-19NoNoHistorical
60505-4779-760505477907120 TABLET in 1 BOTTLE (60505-4779-7) 120 tablet2023-10-19NoNoHistorical