Pazopanib

Product NDC: 42291-939
11-digit product format: 422910939
Labeler code: 42291
Product ID: 42291-939_48c0ee87-f725-1a71-e063-6394a90a72d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pazopanib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA217517
Marketing category: ANDA
Marketing start: 2024-04-23
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: 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-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
2026-08-18 06:07:40	2026-07	A217517-001	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	AB	2023-10-19	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A217517-001	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

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

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
16c5df52-0031-034d-e063-6294a90a1717	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
42291-939-12	Pazopanib	120 in 1 BOTTLE	TABLET, FILM COATED	120		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-939-12	EA - Each	42291-939	095af943-1d00-4a58-994a-4a1fcfe4bc1d	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-939	PAZOPANIB TABLET, FILM COATED [AVKARE]	1	Current NDC, 1 package rows	20240425_16c5df52-0031-034d-e063-6294a90a1717.zip

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 · 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 ndc (product): 42291-939
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

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	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
42291-939-12	42291093912	120 TABLET, FILM COATED in 1 BOTTLE (42291-939-12)	2024-04-23	No	No	Current