Ondansetron Hydrochloride

Product NDC: 50090-3185
11-digit product format: 500903185
Labeler code: 50090
Product ID: 50090-3185_903422be-f6d7-4e24-bd22-699eb89a1954
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078539
Marketing category: ANDA
Marketing start: 2007-07-31
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: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3185	50090-3185-2	D	Discontinued by firm		2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A078539-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078539-001	AB
A078539-002	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.

Product history page 1 of 4 · 132 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
2026-10-15 13:18:30	2026-09	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078539-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078539-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078539-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078539-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078539-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078539-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078539-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078539-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078539-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078539-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078539-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078539-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078539-002	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	8 mg/1

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	SPL version
50090-3185-0	Ondansetron Hydrochloride	4 in 1 BOTTLE	TABLET, FILM COATED	4	11
50090-3185-1	Ondansetron Hydrochloride	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	11
50090-3185-2	Ondansetron Hydrochloride	3 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	3	11
50090-3185-3	Ondansetron Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	11
50090-3185-4	Ondansetron Hydrochloride	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3185-0	EA - Each	50090-3185	0e1eebe4-3c42-4e93-9211-7ee7c5d05881	1	2018-12-13
50090-3185-1	EA - Each	50090-3185	2e924e49-d296-48b8-8df4-dd42d2fc3e17	1	2020-03-10
50090-3185-2	EA - Each	50090-3185	056bb2ee-c644-4c79-87ec-f4ed106c9309	1	2020-03-10
50090-3185-3	EA - Each	50090-3185	f12ee18c-c7c7-4478-a01e-d24d6e913c36	1	2020-03-10
50090-3185-4	EA - Each	50090-3185	32caee76-7484-4291-9bac-6ec22a869659	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3185	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	11	Current NDC, Legacy NDC, 5 package rows	20231027_674ea285-8f84-4603-9655-82200c523fe5.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 4 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	69ed01b7-a94e-4946-a044-a9f8c37616ec	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	08db5ce7-4dcf-4581-a0bf-f405cc22b48d	2018-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539

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
198052	ondansetron HCl 4 MG Oral Tablet	PSN	674ea285-8f84-4603-9655-82200c523fe5	11
312086	ondansetron HCl 8 MG Oral Tablet	PSN	674ea285-8f84-4603-9655-82200c523fe5	11
198052	ondansetron 4 MG Oral Tablet	SCD	674ea285-8f84-4603-9655-82200c523fe5	11
312086	ondansetron 8 MG Oral Tablet	SCD	674ea285-8f84-4603-9655-82200c523fe5	11
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	674ea285-8f84-4603-9655-82200c523fe5	11
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	674ea285-8f84-4603-9655-82200c523fe5	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3185-0	50090318500	4 TABLET, FILM COATED in 1 BOTTLE (50090-3185-0)	2018-01-17	0000-00-00	No	No	Current
50090-3185-1	50090318501	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-1)	2014-11-28	0000-00-00	No	No	Current
50090-3185-2	50090318502	3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-2)	2014-11-28	0000-00-00	No	No	Current
50090-3185-3	50090318503	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-3)	2014-11-28	0000-00-00	No	No	Current
50090-3185-4	50090318504	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-4)	2014-11-28	0000-00-00	No	No	Current