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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219034-001PAZOPANIB HYDROCHLORIDEPAZOPANIB HYDROCHLORIDEEQ 200MG BASETABLET / ORALAB2024-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219034-001AB

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 22:54:322026-06A219034-001PAZOPANIB HYDROCHLORIDEEQ 200MG BASETABLET / ORALAB2024-12-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219034-001AB1a50c72e98297…

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
PazopanibPAZOPANIBAurobindo Pharma Limited25575cc6-5757-4f9b-9c09-0c4deb61ba122024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219034
application number: ANDA219034
ndc (product): 59651-582

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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25575cc6-5757-4f9b-9c09-0c4deb61ba12Available 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
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