Application 076972

Type: ANDA
Sponsor: FRESENIUS KABI USA

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
A076972-001	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
A076972-001	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	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076972-001	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	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076972-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076972-001	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	A076972-001	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	A076972-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076972-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076972-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076972-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076972-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076972-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076972-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076972-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076972-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076972-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076972-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076972-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076972-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076972-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076972-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076972-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076972-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076972-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076972-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076972-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076972-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076972-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076972-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076972-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076972-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076972-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076972-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076972-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076972-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076972-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076972-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076972-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076972-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076972-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076972-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076972-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076972-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076972-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076972-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076972-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	6a231919-6837-4b09-b66d-3706432b9702	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076972 application number: ANDA076972
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0050959-c14c-41b6-9a92-fadc5f6feff3	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076972 application number: ANDA076972 ndc (product): 63323-373
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	993cd1d7-70a1-a431-e053-2a95a90a5771	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076972 application number: ANDA076972 ndc (product): 51662-1366

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1366	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1366	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1366	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65293-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	The Medicines Company	ANDA	Current
65293-373	Ondansetron	ONDANSETRON HYDROCHLORIDE	The Medicines Company	ANDA	Current