ondansetron

Product NDC: 62756-356
Requested package NDC: 62756-356-83
11-digit product format: 627560356
Labeler code: 62756
Product ID: 62756-356_e83d90db-54a7-4c13-bd68-b1620a8aecaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA077557
Marketing category: ANDA
Marketing start: 2007-08-02
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

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	62756-356	62756-356-83	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077557-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02
A077557-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077557-001	AB
A077557-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`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	A077557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup
4AF302ESOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104894	Internal RxNorm lookup
198052	Internal RxNorm lookup
312086	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
92c758a3-e749-4a15-be4b-ee30b364b2b0	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
62756-356-64	ondansetron	3 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	3	18
62756-356-64	ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	18
62756-356-66	ondansetron	1 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	1	18
62756-356-66	ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	18
62756-356-83	ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	18
62756-356-64	ONDANSETRON	3 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	3	5
62756-356-64	ONDANSETRON	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	5
62756-356-66	ONDANSETRON	1 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	1	5
62756-356-66	ONDANSETRON	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	5
62756-356-83	ONDANSETRON	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-356-64	EA - Each	62756-356	99af3801-0b2d-4e82-bcd1-87f45821e8db	1	2012-07-24
62756-356-66	EA - Each	62756-356	ae8758cf-37c2-468a-bdaa-09af7f5654dd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	4
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	3
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-356	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]	17	Current NDC, Legacy NDC, 5 package rows	20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.zip
62756-356	ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	5	Current NDC, Legacy NDC, 5 package rows	20150505_52dc6871-47d3-11dc-99cc-f742b487c00e.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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON	Cardinal Health 107, LLC	26aff90c-49ea-46ac-bbf3-c188c2b061c9	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (package): 62756-356-83 ndc (product): 62756-356 ndc11 (package): 62756035683
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	b297c163-2052-cb22-e053-2995a90a8289	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557

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
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron HCl 4 MG Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron HCl 8 MG Oral Tablet	PSN	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron 4 MG Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron 8 MG Oral Tablet	SCD	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	92c758a3-e749-4a15-be4b-ee30b364b2b0	18
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron HCl 4 MG Oral Tablet	PSN	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron 4 MG Oral Tablet	SCD	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	13
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	52dc6871-47d3-11dc-99cc-f742b487c00e	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	52dc6871-47d3-11dc-99cc-f742b487c00e	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	5
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	52dc6871-47d3-11dc-99cc-f742b487c00e	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	52dc6871-47d3-11dc-99cc-f742b487c00e	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	5
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	b297c163-2052-cb22-e053-2995a90a8289	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	b297c163-2052-cb22-e053-2995a90a8289	3
104894	ondansetron 4 MG Disintegrating Oral Tablet	PSN	6c450150-a7a4-46f3-b62a-848eeefada06	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	6c450150-a7a4-46f3-b62a-848eeefada06	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	a799a6ec-917a-33c9-e053-2995a90a2df3	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	d9bc4bcd-8466-3b02-e053-2a95a90a635f	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	6285d09e-8f9b-419b-80fb-be7eb2523490	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	1fc05030-6521-6d38-e063-6294a90a0f8b	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	1fbfe3f9-e0da-a3a2-e063-6294a90ab6aa	1
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	6c450150-a7a4-46f3-b62a-848eeefada06	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	d9bc4bcd-8466-3b02-e053-2a95a90a635f	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	1fbfe3f9-e0da-a3a2-e063-6294a90ab6aa	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	a799a6ec-917a-33c9-e053-2995a90a2df3	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	6c450150-a7a4-46f3-b62a-848eeefada06	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	6285d09e-8f9b-419b-80fb-be7eb2523490	1
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	1fc05030-6521-6d38-e063-6294a90a0f8b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-356-83	62756035683	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-356-83)	2007-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ondansetron hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-06-12	Human Prescription Drug Label	18
ondansetron hydrochloride	Bryant Ranch Prepack	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	13
ondansetron	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
ondansetron	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
ondansetron	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
ondansetron	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
ondansetron	REMEDYREPACK INC.	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	7
ondansetron	A-S Medication Solutions	2023-12-16	Human Prescription Drug Label	8
Ondansetron Orally Disintegrating Tablets	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ondansetron Orally Disintegrating Tablets	NuCare Pharmaceuticals,Inc.	2022-03-08	HUMAN PRESCRIPTION DRUG LABEL	1
ondansetron	Preferred Pharmaceuticals, Inc.	2021-08-20	HUMAN PRESCRIPTION DRUG LABEL	2
ondansetron	St. Mary's Medical Park Pharmacy	2020-07-07	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Orally Disintegrating Tablets	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
ondansetron	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron Orally Disintegrating Tablets	Sun Pharmaceutical Industries Limited	2015-05-05	Human Prescription Drug Label	5
Ondansetron Orally Disintegrating Tablets	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1