FDA.reportPublic FDA data

pazopanib

Product NDC
13668-735
11-digit product format
136680735
Labeler code
13668
Product ID
13668-735_6b6119a9-55d1-4a4d-a0aa-d287024a9ed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pazopanib hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA219922
Marketing category
ANDA
Marketing start
2025-09-04
Substance
PAZOPANIB HYDROCHLORIDE
Active strength
400 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
2027-12-31
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
A219922-001PAZOPANIB HYDROCHLORIDEPAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-04

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219922-001CGT2026-05-06

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 22:54:322026-06A219922-001PAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-04a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06A219922-001CGT2026-05-06a50c72e98297…

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
pazopanibPAZOPANIB HYDROCHLORIDETorrent Pharmaceuticals Limited7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219922
application number: ANDA219922
ndc (product): 13668-735

Additional Listing Data#

Finished product
Yes
Brand name base
pazopanib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAZOPANIB HYDROCHLORIDE400 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
867508Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7235fad0-eb5b-4fdf-a362-c8c65c9bfe1dAvailable 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
13668-735-30pazopanib30 in 1 BOTTLETABLET, FILM COATED303
13668-735-60pazopanib60 in 1 BOTTLETABLET, FILM COATED603
13668-735-90pazopanib90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-735-30EA - Each13668-73565770148-48c3-43e8-bc76-f8f71f33b9ed12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
867508PAZOPanib 400 MG Oral TabletPSN7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d3
867508pazopanib 400 MG Oral TabletSCD7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d3
867508pazopanib HCl 400 MG Oral TabletSY7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-735-301366807353030 TABLET, FILM COATED in 1 BOTTLE (13668-735-30) 2025-09-04NoNoCurrent
13668-735-601366807356060 TABLET, FILM COATED in 1 BOTTLE (13668-735-60) 2025-09-04NoNoCurrent
13668-735-901366807359090 TABLET, FILM COATED in 1 BOTTLE (13668-735-90) 2025-09-04NoNoCurrent