ONDANSETRON

Product NDC: 63629-4306
Requested package NDC: 63629-4306-9
11-digit product format: 636294306
Labeler code: 63629
Product ID: 63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4306	63629-4306-9	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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 · 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
198052	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
384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4306-0	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-1	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-2	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-3	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-4	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-5	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-6	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-7	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-8	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-9	2020-10-16	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-0	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-1	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-2	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-3	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-4	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-5	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-6	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-7	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-8	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-9	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-4306-0	ONDANSETRON	3 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	3	13
63629-4306-1	ONDANSETRON	30 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	30	13
63629-4306-2	ONDANSETRON	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	13
63629-4306-3	ONDANSETRON	5 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	5	13
63629-4306-4	ONDANSETRON	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4	13
63629-4306-5	ONDANSETRON	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	13
63629-4306-6	ONDANSETRON	14 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	14	13
63629-4306-7	ONDANSETRON	60 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	60	13
63629-4306-8	ONDANSETRON	12 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	12	13
63629-4306-9	ONDANSETRON	90 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4306-1	EA - Each	63629-4306	3b19adee-ad7a-403c-9184-661a18d95a6d	1	2012-07-24
63629-4306-2	EA - Each	63629-4306	5588a318-3773-41e3-a019-d1a05501deac	1	2012-07-24
63629-4306-3	EA - Each	63629-4306	02b79ace-a07c-4f84-a443-172291719d38	1	2012-07-24
63629-4306-4	EA - Each	63629-4306	cb3da74d-07dd-4f2f-b51d-1ce3d0520c66	1	2013-02-13
63629-4306-5	EA - Each	63629-4306	d6b93a17-f157-4669-a854-7df64fb0a27b	1	2013-02-13
63629-4306-6	EA - Each	63629-4306	7b038889-8ab6-4f32-bc50-36a232fc3226	1	2013-02-13
63629-4306-7	EA - Each	63629-4306	f50e7360-f2bf-4e8c-8c4b-cbedfff8911f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4306	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	12	Current NDC, Legacy NDC, 10 package rows	20240602_384a5cfb-05dd-2b79-73f4-a01a47a9eb3e.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
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 ndc (package): 63629-4306-9 ndc (product): 63629-4306 ndc11 (package): 63629430609
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4306-9	63629430609	90 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)	2010-08-20	0000-00-00	No	No	Current