Ondansetron

Product NDC: 57237-078
11-digit product format: 572370078
Labeler code: 57237
Product ID: 57237-078_49380e9c-090e-44fd-b2c9-992e25e26753
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA090469
Marketing category: ANDA
Marketing start: 2010-04-12
Substance: ONDANSETRON
Active strength: 8 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090469-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12
A090469-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090469-001	AB
A090469-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090469-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090469-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090469-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090469-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090469-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090469-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090469-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090469-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090469-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090469-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090469-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090469-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090469-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090469-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090469-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090469-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090469-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090469-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090469-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090469-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090469-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090469-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090469-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090469-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090469-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090469-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090469-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090469-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090469-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ondansetron
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4AF302ESOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104894	Internal RxNorm lookup
312087	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
eb74425c-c635-4d99-8e98-e63e7359fb89	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-078-01	Ondansetron	100 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	100	15
57237-078-10	Ondansetron	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	15
57237-078-10	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	15
57237-078-30	Ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	15
57237-078-50	Ondansetron	500 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	500	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-078-10	EA - Each	57237-078	eb6914e6-2374-48f8-8626-912a211c4ee5	1	2015-01-05
57237-078-30	EA - Each	57237-078	98bf3286-f3f9-4c66-8a9c-f69e02ce4401	1	2016-03-04
57237-078-50	EA - Each	57237-078	843296a7-dbe4-479c-aec2-882c3918021d	1	2024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-078	ONDANSETRON TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]	14	Current NDC, Legacy NDC, 5 package rows	20240730_eb74425c-c635-4d99-8e98-e63e7359fb89.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Sportpharm LLC	3c4cda2f-13d9-42c5-b449-77deb06c8de5	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	HAWAII REPACK, INC.	b76c5cc9-f1ca-428b-8989-36a66802b650	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	18063a64-a4c0-4bad-911b-00df5c7bb65d	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	77397df5-5a4f-41b2-98bc-f817a1e497fc	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Sportpharm LLC	822404ad-af08-4c62-ae38-7d9819e86079	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	3207cf04-73b7-24ce-e054-00144ff8d46c	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
ONDANSETRON	ONDANSETRON	Direct Rx	b38feff2-900a-4e0c-8260-8f090edbc0bc	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	A-S Medication Solutions	378d0963-d026-4478-8202-fbb636904a37	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	9dff6676-e69e-779d-e053-2995a90a7c81	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	76666e7e-3312-6f9d-e053-2991aa0af705	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f2b502e2-03ed-fe5c-e053-2995a90a368e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	db9a0d22-9339-4319-e053-2a95a90a9592	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	e07c38c0-e1c2-01de-e053-2995a90a390a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	9558d296-8edd-4aa1-875a-6247f9a8374d	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	10afd68b-877f-4819-a314-39f2d56d5db9	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	66ac9c17-bea7-4f8d-8a27-a1e0f9e65945	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	70b48280-ef74-472b-abc3-128962bfcb05	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Rising Pharma Holdings, Inc.	eb74425c-c635-4d99-8e98-e63e7359fb89	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469 ndc (product): 57237-078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	d9321ef6-9fe5-4631-9c58-534fd963cf17	104
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	d9321ef6-9fe5-4631-9c58-534fd963cf17	104
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	eb74425c-c635-4d99-8e98-e63e7359fb89	15
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	eb74425c-c635-4d99-8e98-e63e7359fb89	15
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	eb74425c-c635-4d99-8e98-e63e7359fb89	15
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	eb74425c-c635-4d99-8e98-e63e7359fb89	15
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	84234d20-aa73-446f-9a1b-846e0cb80cec	10
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	84234d20-aa73-446f-9a1b-846e0cb80cec	10
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	70b48280-ef74-472b-abc3-128962bfcb05	7
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	70b48280-ef74-472b-abc3-128962bfcb05	7
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	72f29916-0f95-102d-e053-2991aa0aa5cd	6
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	72f29916-0f95-102d-e053-2991aa0aa5cd	6
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	ec6fe851-d577-5da5-e053-2a95a90a3dbc	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	e07c38c0-e1c2-01de-e053-2995a90a390a	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	d11a99e2-3af2-4f6c-b0bb-1edd1ece135c	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	d11a99e2-3af2-4f6c-b0bb-1edd1ece135c	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	ec6fe851-d577-5da5-e053-2a95a90a3dbc	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	e07c38c0-e1c2-01de-e053-2995a90a390a	5
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	e436e361-da0f-7d6d-e053-2995a90a10e4	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	d1f6fa30-0ac8-e951-e053-2a95a90a6754	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	3c4cda2f-13d9-42c5-b449-77deb06c8de5	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	e436e361-da0f-7d6d-e053-2995a90a10e4	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	47e26779-9465-410c-96b3-091119ae62f2	3
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	e436e361-da0f-7d6d-e053-2995a90a10e4	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	3c4cda2f-13d9-42c5-b449-77deb06c8de5	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	47e26779-9465-410c-96b3-091119ae62f2	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	e436e361-da0f-7d6d-e053-2995a90a10e4	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	d1f6fa30-0ac8-e951-e053-2a95a90a6754	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	e8823f01-ad74-0dd0-e053-2a95a90aa315	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	e8823f01-ad74-0dd0-e053-2a95a90aa315	2
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	77397df5-5a4f-41b2-98bc-f817a1e497fc	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	77397df5-5a4f-41b2-98bc-f817a1e497fc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-078-01	57237007801	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-01)		2024-09-30		No	No	Current
57237-078-10	57237007810	3 BLISTER PACK in 1 CARTON (57237-078-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2010-04-12	0000-00-00	No	No	Current
57237-078-30	57237007830	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-30)		2010-04-12	0000-00-00	No	No	Current
57237-078-50	57237007850	500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-50)		2024-09-30		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Preferred Pharmaceuticals, Inc.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	9
Ondansetron	Sportpharm LLC	2026-08-03	HUMAN PRESCRIPTION DRUG LABEL	4
Ondansetron	Bryant Ranch Prepack	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron	ST. MARY'S MEDICAL PARK PHARMACY	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-07-17	Human Prescription Drug Label	15
Ondansetron	NuCare Pharmaceuticals,Inc.	2025-06-24	HUMAN PRESCRIPTION DRUG LABEL	6
Ondansetron	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	104
Ondansetron	REMEDYREPACK INC.	2024-03-28	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	NuCare Pharmaceuticals,Inc.	2023-12-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron	A-S Medication Solutions	2023-10-16	Human Prescription Drug Label	10
Ondansetron	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
Ondansetron	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	Proficient Rx LP	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3