FDA.reportPublic FDA data

Pazopanib

Product NDC
59651-582
11-digit product format
596510582
Labeler code
59651
Product ID
59651-582_25575cc6-5757-4f9b-9c09-0c4deb61ba12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pazopanib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219034
Marketing category
ANDA
Marketing start
2024-12-04
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
59651-582-08Pazopanib120 in 1 BOTTLETABLET, FILM COATED1201
59651-582-30Pazopanib30 in 1 BOTTLETABLET, FILM COATED301
59651-582-90Pazopanib90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-582-08EA - Each59651-5822c81af08-04ad-48e4-9ca7-fb9dbbda10c212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-582PAZOPANIB TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20241208_25575cc6-5757-4f9b-9c09-0c4deb61ba12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867502PAZOPanib 200 MG Oral TabletPSN25575cc6-5757-4f9b-9c09-0c4deb61ba121
867502pazopanib 200 MG Oral TabletSCD25575cc6-5757-4f9b-9c09-0c4deb61ba121
867502pazopanib (as pazopanib hydrochloride) 200 MG Oral TabletSY25575cc6-5757-4f9b-9c09-0c4deb61ba121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-582-0859651058208120 TABLET, FILM COATED in 1 BOTTLE (59651-582-08) 2024-12-04NoNoCurrent
59651-582-305965105823030 TABLET, FILM COATED in 1 BOTTLE (59651-582-30) 2024-12-04NoNoCurrent
59651-582-905965105829090 TABLET, FILM COATED in 1 BOTTLE (59651-582-90) 2024-12-04NoNoCurrent