Ondansetron Hydrochloride

Product NDC: 51672-4109
11-digit product format: 516724109
Labeler code: 51672
Product ID: 51672-4109_288442cd-0f6b-49e1-9acc-d8f613f54810
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA077729
Marketing category: ANDA
Marketing start: 2011-03-28
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-4109		D	Discontinued by firm	2026-10-05
excluded package	package	51672-4109	51672-4109-0	D	Discontinued by firm	2026-10-05
excluded package	package	51672-4109	51672-4109-6	D	Discontinued by firm	2026-10-05
excluded package	package	51672-4109	51672-4109-8	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077729-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28
A077729-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28
A077729-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077729-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2011-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077729-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077729-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2011-03-28	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ondansetron Hydrochloride	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
Ondansetron	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
talc	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [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
51672-4109	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.]	5	Legacy NDC	20180223_29cda698-cfd4-43e1-b69e-884d08d8918a.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4109-0	51672410900	1 BLISTER PACK in 1 CARTON (51672-4109-0) > 100 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2011-03-28	0000-00-00	No	No	Current
51672-4109-6	51672410906	30 TABLET, FILM COATED in 1 BOTTLE (51672-4109-6)		2011-03-28	0000-00-00	No	No	Current
51672-4109-8	51672410908	1 BLISTER PACK in 1 CARTON (51672-4109-8) > 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2011-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Hydrochloride	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2018-02-15	HUMAN PRESCRIPTION DRUG LABEL	5