Application 077541

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No

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
A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2006-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077541-001	AP

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.

Product history page 1 of 2 · 41 observed 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	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077541-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077541-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077541-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077541-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077541-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077541-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077541-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077541-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077541-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077541-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077541-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077541-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077541-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077541-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077541-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077541-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077541-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077541-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077541-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077541-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077541-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077541-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077541-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077541-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077541-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077541-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077541-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077541-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077541-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077541-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077541-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077541-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077541-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077541-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077541-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077541-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077541-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077541-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077541-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077541-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077541-001	AP	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Civica, Inc.	70437694-0341-4f3b-824c-06843403443f	2026-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 72572-520
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	97713356-f42b-4a67-95f6-561afa68c0c2	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 0641-6080
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	c29ca6df-621d-44b6-98fc-b48666573366	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 0641-6078
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	61758670-91ab-4422-8d9d-e8ca87eecae8	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 55154-2877
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	ee1f115f-c8f8-4526-b827-c8e48aeb5050	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 55154-2876
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	768aa02b-8231-5799-e053-2a91aa0a618d	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 51662-1245
Ondansetron	ONDANSETRON	Medical Purchasing Solutions, LLC	70bf93bc-e979-f080-e053-2991aa0a21df	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077541 application number: ANDA077541 ndc (product): 71872-7140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6078	Ondansetron	Ondansetron	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6078	Ondansetron	Ondansetron	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6078	Ondansetron	Ondansetron	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6080	Ondansetron	Ondansetron	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6080	Ondansetron	Ondansetron	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6080	Ondansetron	Ondansetron	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1245	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1245	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1245	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1245	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-2876	Ondansetron	Ondansetron	Cardinal Health	ANDA	Current
55154-2876	Ondansetron	Ondansetron	Cardinal Health	ANDA	Current
55154-2876	Ondansetron	Ondansetron	Cardinal Health 107, LLC	ANDA	Current
55154-2877	Ondansetron	Ondansetron	Cardinal Health 107, LLC	ANDA	Current
55154-2877	Ondansetron	Ondansetron	Cardinal Health	ANDA	Current
71872-7140	Ondansetron	Ondansetron	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7140	Ondansetron	Ondansetron	Medical Purchasing Solutions, LLC	ANDA	Current
72572-520	Ondansetron	Ondansetron	Civica, Inc.	ANDA	Current
72572-520	Ondansetron	Ondansetron	Civica, Inc.	ANDA	Current
72572-520	Ondansetron	Ondansetron	Civica, Inc.	ANDA	Current