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 42.

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
2026-08-18 06:07:402026-07A219922-001PAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219922-001PAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219922-001PAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-0431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219922-001PAZOPANIB HYDROCHLORIDEEQ 400MG BASETABLET / ORAL2025-09-04a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A219922-001CGT2026-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219922-001CGT2026-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219922-001CGT2026-05-0631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219922-001CGT2026-05-06a50c72e98297…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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