Ondansetron Hydrochloride

Product NDC: 76420-915
Requested package NDC: 76420-915-10
11-digit product format: 764200915
Labeler code: 76420
Product ID: 76420-915_2cbe06c2-92c4-f72d-e063-6294a90aede8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA078539
Marketing category: ANDA
Marketing start: 2007-07-31
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/1
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

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	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 · 129 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
2026-09-14 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	A078539-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078539-002	AB	1	`74a2ff9319b5…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198052	Internal RxNorm lookup
312084	Internal RxNorm lookup
312086	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
65b0b2e2-37fd-4d08-9674-954d62bb531a	Available on FDA.report

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
76420-915-00	Ondansetron Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1
76420-915-03	Ondansetron Hydrochloride	3 in 1 BOTTLE	TABLET, FILM COATED	3	1
76420-915-05	Ondansetron Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	1
76420-915-10	Ondansetron Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
76420-915-11	Ondansetron Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1
76420-915-11	Ondansetron Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	1
76420-915-30	Ondansetron Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
76420-915-33	Ondansetron Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	1
76420-915-33	Ondansetron Hydrochloride	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	1
76420-915-60	Ondansetron Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
76420-915-90	Ondansetron Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-915	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCLEMED USA, INC.]	1	Current NDC, 11 package rows	20250130_65b0b2e2-37fd-4d08-9674-954d62bb531a.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 1 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	960e2104-18c3-4cfa-abf6-f1b30c452918	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	416be720-82e8-4a6d-8531-c1a29869daae	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	5566aebb-d84d-6d6a-e063-6294a90a746f	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2a30d534-4607-4882-865e-56d2364acaad	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	14276805-4e99-4bbe-ad76-ffc06eddb38a	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	00b17a8e-9d38-a8d4-e063-6294a90a153e	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	0a14eb9a-0385-40e9-a7ec-71435450ac91	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57b0a1e5-5dfa-64a0-e063-6394a90acf36	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	3f2e8efe-7fd4-407c-a77b-bd6dd04608e2	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	ee3e8cbe-4f0b-4361-a1b5-8329d85a2932	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	561dce26-92fa-e00b-e063-6294a90a1ab2	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	58f16a00-3e66-29de-e053-2991aa0a59a0	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	American Health Packaging	9f015e60-1aec-4ae7-b28f-42f6c8f50455	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Coupler LLC	546191d2-d092-6342-e063-6294a90a0cd3	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Redpharm Drug	541b9a0d-ae94-db6f-e063-6394a90a9805	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	c0be25a0-e13d-4242-93dc-0b86e82aadd7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	5cc67d95-6629-4451-9e34-2f7a60482be5	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	b1324076-f83e-4816-9e02-6b2a689010bc	2026-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron HCL	ONDANSETRON HCL	Advanced Rx of Tennessee, LLC	af735f22-6d6c-6e1f-e053-2a95a90a3532	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	e2c0e86c-e7fc-48f9-a894-02da8761001c	2026-03-05	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
312084	ondansetron 24 MG Oral Tablet	PSN	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
198052	ondansetron HCl 4 MG Oral Tablet	PSN	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
312086	ondansetron HCl 8 MG Oral Tablet	PSN	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
312084	ondansetron 24 MG Oral Tablet	SCD	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
198052	ondansetron 4 MG Oral Tablet	SCD	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
312086	ondansetron 8 MG Oral Tablet	SCD	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
312084	ondansetron 24 MG (ondansetron hydrochloride dihydrate 30 MG) Oral Tablet	SY	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	65b0b2e2-37fd-4d08-9674-954d62bb531a	1
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	65b0b2e2-37fd-4d08-9674-954d62bb531a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-915-10	76420091510	10 TABLET, FILM COATED in 1 BOTTLE (76420-915-10)	2025-01-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-01-27	HUMAN PRESCRIPTION DRUG LABEL	1