Ondansetron

Product NDC: 51672-4091
11-digit product format: 516724091
Labeler code: 51672
Product ID: 51672-4091_e10032ef-6d48-44cb-9b7f-9a338f35ca51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA077009
Marketing category: ANDA
Marketing start: 2007-11-30
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/5mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51672-4091		D	Discontinued by firm		2026-08-03
excluded package	package	51672-4091	51672-4091-3	D	Discontinued by firm		2026-08-03

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
A077009-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL			2007-11-30

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	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL		2007-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077009-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A077009-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077009-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077009-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077009-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077009-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077009-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077009-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077009-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077009-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077009-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077009-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077009-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077009-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077009-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077009-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077009-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077009-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077009-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077009-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077009-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077009-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077009-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077009-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077009-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077009-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077009-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077009-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9bd4853-037c-6968-f4d4-9bb9a0efd1ea	Product name	2	20250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4091-3	Ondansetron	1 in 1 CARTON	SOLUTION	1		7
51672-4091-3	Ondansetron	50 mL in 1 BOTTLE	SOLUTION	50		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4091-3	ML - Milliliter	51672-4091	c6bdd593-cc17-434d-9471-2e972a725cd2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ondansetron Hydrochloride	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
ondansetron	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4091	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	7	Current NDC, Legacy NDC, 2 package rows	20190607_a95ca4f4-c4de-4822-9a08-209d10bf5136.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	a95ca4f4-c4de-4822-9a08-209d10bf5136	7
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	a95ca4f4-c4de-4822-9a08-209d10bf5136	7
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	a95ca4f4-c4de-4822-9a08-209d10bf5136	7
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	a95ca4f4-c4de-4822-9a08-209d10bf5136	7
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	b7dac63f-556b-4965-ae4e-51330a79ab47	2
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	b7dac63f-556b-4965-ae4e-51330a79ab47	2
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	b7dac63f-556b-4965-ae4e-51330a79ab47	2
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	b7dac63f-556b-4965-ae4e-51330a79ab47	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4091-3	51672409103	1 BOTTLE in 1 CARTON (51672-4091-3) / 50 mL in 1 BOTTLE	1 bottle	2007-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2019-06-04	HUMAN PRESCRIPTION DRUG LABEL	7
Ondansetron	Unit Dose Services	2018-04-03	HUMAN PRESCRIPTION DRUG LABEL	2