Pazopanib

Product NDC: 0480-4184
11-digit product format: 004804184
Labeler code: 0480
Product ID: 0480-4184_048bbf33-5176-40b9-a6ed-ee377d7d078b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pazopanib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals, Inc.
Application: ANDA217517
Marketing category: ANDA
Marketing start: 2023-10-20
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217517-001	PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB		2023-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217517-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217517-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217517-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217517-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217517-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217517-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217517-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217517-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217517-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217517-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217517-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217517-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217517-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217517-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217517-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217517-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217517-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217517-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217517-001	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217517-001	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pazopanib	PAZOPANIB	AvKARE	16c5df52-0031-034d-e063-6294a90a1717	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217517 application number: ANDA217517
Pazopanib	PAZOPANIB	Teva Pharmaceuticals, Inc.	9f7ea520-a152-401e-b1f7-b5ef8c7a2239	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217517 application number: ANDA217517 ndc (product): 0480-4184

Additional Listing Data#

Finished product: Yes
Brand name base: Pazopanib
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAZOPANIB HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33Y9ANM545	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f7ea520-a152-401e-b1f7-b5ef8c7a2239	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a22552f9-c212-7ece-256c-f50df49d1fe2	Product name	2	20250204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0480-4184-89	Pazopanib	120 in 1 BOTTLE	TABLET, FILM COATED	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-4184	PAZOPANIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]	3	Current NDC, 1 package rows	20240601_9f7ea520-a152-401e-b1f7-b5ef8c7a2239.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33Y9ANM545	PAZOPANIB HYDROCHLORIDE	635702-64-6	PAZOPANIB HYDROCHLORIDE
7RN5DR86CK	PAZOPANIB	444731-52-6	Pazopanib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
867502	PAZOPanib 200 MG Oral Tablet	PSN	9f7ea520-a152-401e-b1f7-b5ef8c7a2239	3
867502	pazopanib 200 MG Oral Tablet	SCD	9f7ea520-a152-401e-b1f7-b5ef8c7a2239	3
867502	pazopanib (as pazopanib hydrochloride) 200 MG Oral Tablet	SY	9f7ea520-a152-401e-b1f7-b5ef8c7a2239	3
867502	PAZOPanib 200 MG Oral Tablet	PSN	16c5df52-0031-034d-e063-6294a90a1717	2
867502	pazopanib 200 MG Oral Tablet	SCD	16c5df52-0031-034d-e063-6294a90a1717	2
867502	pazopanib (as pazopanib hydrochloride) 200 MG Oral Tablet	SY	16c5df52-0031-034d-e063-6294a90a1717	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0480-4184-89	00480418489	120 TABLET, FILM COATED in 1 BOTTLE (0480-4184-89)	2023-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pazopanib	AvKARE	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Pazopanib	Teva Pharmaceuticals, Inc.	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	3