Ondansetron Hydrochloride

Product NDC: 57237-075
11-digit product format: 572370075
Labeler code: 57237
Product ID: 57237-075_523d3416-6472-44c4-abc0-13df8f875e00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, 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 1.

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 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	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…`
2019-12-13 00:20 UTC	2019-12	A078539-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078539-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078539-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078539-003	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198052	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
90e0e508-75f7-4c8b-bb38-898aa4c531c3	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	Strength	SPL version
57237-075-30	Ondansetron Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		11
57237-075-50	Ondansetron Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-075-30	EA - Each	57237-075	73768b4e-ca6f-4572-ba57-eb5bc69dc8a9	1	2016-04-04
57237-075-50	EA - Each	57237-075	9804734c-bfd1-4d30-bb54-b3cb428a10ec	1	2022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-075	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20231215_90e0e508-75f7-4c8b-bb38-898aa4c531c3.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	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	Proficient Rx LP	0a14eb9a-0385-40e9-a7ec-71435450ac91	2026-07-01	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	2026-06-29	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	St. Mary's Medical Park Pharmacy	00b17a8e-9d38-a8d4-e063-6294a90a153e	2026-06-15	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
ONDANSETRON	ONDANSETRON	Direct_Rx	90b73778-2ab5-5460-e053-2a95a90abbc1	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	e0f69f57-aeb9-4890-85aa-e5976208e8be	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f76d27c5-acd4-482c-e053-6294a90a5284	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f29f8ae1-4826-d8eb-e053-2a95a90a691a	2026-01-01	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	8585e68b-965f-4f95-a5df-eea023cd5f82	105
198052	ondansetron 4 MG Oral Tablet	SCD	8585e68b-965f-4f95-a5df-eea023cd5f82	105
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	8585e68b-965f-4f95-a5df-eea023cd5f82	105
198052	ondansetron HCl 4 MG Oral Tablet	PSN	e2c0e86c-e7fc-48f9-a894-02da8761001c	101
198052	ondansetron 4 MG Oral Tablet	SCD	e2c0e86c-e7fc-48f9-a894-02da8761001c	101
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	e2c0e86c-e7fc-48f9-a894-02da8761001c	101
198052	ondansetron HCl 4 MG Oral Tablet	PSN	674ea285-8f84-4603-9655-82200c523fe5	11
198052	ondansetron HCl 4 MG Oral Tablet	PSN	90e0e508-75f7-4c8b-bb38-898aa4c531c3	11
312086	ondansetron HCl 8 MG Oral Tablet	PSN	90e0e508-75f7-4c8b-bb38-898aa4c531c3	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
198052	ondansetron 4 MG Oral Tablet	SCD	90e0e508-75f7-4c8b-bb38-898aa4c531c3	11
312086	ondansetron 8 MG Oral Tablet	SCD	90e0e508-75f7-4c8b-bb38-898aa4c531c3	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	90e0e508-75f7-4c8b-bb38-898aa4c531c3	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	90e0e508-75f7-4c8b-bb38-898aa4c531c3	11
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	674ea285-8f84-4603-9655-82200c523fe5	11
198052	ondansetron HCl 4 MG Oral Tablet	PSN	681795c0-1037-e373-e053-2991aa0af7b2	5
198052	ondansetron 4 MG Oral Tablet	SCD	681795c0-1037-e373-e053-2991aa0af7b2	5
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	681795c0-1037-e373-e053-2991aa0af7b2	5
198052	ondansetron HCl 4 MG Oral Tablet	PSN	2e0b1b09-9e68-4728-82d5-1f86510a0f2a	4
198052	ondansetron HCl 4 MG Oral Tablet	PSN	960e2104-18c3-4cfa-abf6-f1b30c452918	4
198052	ondansetron HCl 4 MG Oral Tablet	PSN	852a3251-bf28-5557-e053-2991aa0a4fbd	4
198052	ondansetron 4 MG Oral Tablet	SCD	2e0b1b09-9e68-4728-82d5-1f86510a0f2a	4
198052	ondansetron 4 MG Oral Tablet	SCD	852a3251-bf28-5557-e053-2991aa0a4fbd	4
198052	ondansetron 4 MG Oral Tablet	SCD	960e2104-18c3-4cfa-abf6-f1b30c452918	4
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	960e2104-18c3-4cfa-abf6-f1b30c452918	4
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	852a3251-bf28-5557-e053-2991aa0a4fbd	4
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	2e0b1b09-9e68-4728-82d5-1f86510a0f2a	4
198052	ondansetron HCl 4 MG Oral Tablet	PSN	f1e04ccb-60c4-4f9a-acd7-70b1c9bee036	3
198052	ondansetron HCl 4 MG Oral Tablet	PSN	3a79fc2b-9ea3-a808-e063-6394a90ae794	3
198052	ondansetron 4 MG Oral Tablet	SCD	3a79fc2b-9ea3-a808-e063-6394a90ae794	3
198052	ondansetron 4 MG Oral Tablet	SCD	f1e04ccb-60c4-4f9a-acd7-70b1c9bee036	3
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	3a79fc2b-9ea3-a808-e063-6394a90ae794	3
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	f1e04ccb-60c4-4f9a-acd7-70b1c9bee036	3
198052	ondansetron HCl 4 MG Oral Tablet	PSN	36d64400-2d13-4a1a-a1ca-4741cd3d3f1a	2
198052	ondansetron 4 MG Oral Tablet	SCD	36d64400-2d13-4a1a-a1ca-4741cd3d3f1a	2
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	36d64400-2d13-4a1a-a1ca-4741cd3d3f1a	2
198052	ondansetron HCl 4 MG Oral Tablet	PSN	26a62675-50a8-5681-e063-6394a90a5521	1
198052	ondansetron HCl 4 MG Oral Tablet	PSN	7df06aee-5db2-9f4c-e053-2a91aa0aa354	1
198052	ondansetron HCl 4 MG Oral Tablet	PSN	40106070-6a25-5b0e-e063-6394a90a4197	1
198052	ondansetron 4 MG Oral Tablet	SCD	7df06aee-5db2-9f4c-e053-2a91aa0aa354	1
198052	ondansetron 4 MG Oral Tablet	SCD	40106070-6a25-5b0e-e063-6394a90a4197	1
198052	ondansetron 4 MG Oral Tablet	SCD	26a62675-50a8-5681-e063-6394a90a5521	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	7df06aee-5db2-9f4c-e053-2a91aa0aa354	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	40106070-6a25-5b0e-e063-6394a90a4197	1
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	26a62675-50a8-5681-e063-6394a90a5521	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-075-30	57237007530	30 TABLET, FILM COATED in 1 BOTTLE (57237-075-30)	2007-07-31	0000-00-00	No	No	Current
57237-075-50	57237007550	500 TABLET, FILM COATED in 1 BOTTLE (57237-075-50)	2022-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Unit Dose Solutions, Inc.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Proficient Rx LP	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride	Unit Dose Solutions, Inc.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Redpharm Drug	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Bryant Ranch Prepack	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	101
Ondansetron Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron Hydrochloride	REMEDYREPACK INC.	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron Hydrochloride	PHOENIX RX LLC	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron Hydrochloride	PHOENIX RX LLC	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Preferred Pharmaceuticals Inc.	2025-09-03	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-09-01	Human Prescription Drug Label	11
Ondansetron Hydrochloride	Quality Care Products, LLC	2024-12-19	Human Prescription Drug Label	4
Ondansetron Hydrochloride	Coupler LLC \| Aurobindo Pharma Limited	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Bryant Ranch Prepack	2024-08-21	HUMAN PRESCRIPTION DRUG LABEL	105
ondansetron	RedPharm Drug, Inc.	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron Hydrochloride	A-S Medication Solutions	2023-10-25	Human Prescription Drug Label	11
Ondansetron Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3
Ondansetron Hydrochloride	Preferred Pharmaceuticals Inc.	2023-04-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Hydrochloride	Clinical Solutions Wholesale, LLC	2020-09-03	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron Hydrochloride	medsource pharmaceuticals	2018-12-26	HUMAN PRESCRIPTION DRUG LABEL	1