Ondansetron

Product NDC: 50090-1658
11-digit product format: 500901658
Labeler code: 50090
Product ID: 50090-1658_7e052bf8-036e-4239-a013-f7d21537ba5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078152
Marketing category: ANDA
Marketing start: 2007-06-27
Substance: ONDANSETRON
Active strength: 4 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078152-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-06-27
A078152-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078152-001	AB
A078152-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078152-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078152-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-27	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078152-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078152-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078152-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078152-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078152-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078152-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078152-002	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ondansetron
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON	4 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
5a81a39b-051b-414e-a6b0-d844de4e9ab4	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1658-0	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-0	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-0	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-03-16	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-0	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-0	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-0	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-1	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-2	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-1658-3	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON 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
50090-1658-0	Ondansetron	1 in 1 PACKET	TABLET, ORALLY DISINTEGRATING	1	21
50090-1658-0	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	21
50090-1658-1	Ondansetron	1 in 1 PACKET	TABLET, ORALLY DISINTEGRATING	1	21
50090-1658-1	Ondansetron	20 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	20	21
50090-1658-2	Ondansetron	5 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	5	21
50090-1658-2	Ondansetron	1 in 1 PACKAGE	TABLET, ORALLY DISINTEGRATING	1	21
50090-1658-3	Ondansetron	30 in 1 BOX, UNIT-DOSE	TABLET, ORALLY DISINTEGRATING	30	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1658-0	EA - Each	50090-1658	017e302b-d747-4f1e-8319-76e834c7a701	1	2018-11-06
50090-1658-1	EA - Each	50090-1658	0893feae-0043-4f4d-b8d7-2c122231d97f	1	2018-08-13
50090-1658-2	EA - Each	50090-1658	4ddeecd5-83b4-4a7c-a788-f82737f8a1b3	1	2018-08-13
50090-1658-3	EA - Each	50090-1658	a87e82db-4edc-4694-b741-4ce1575f5b28	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1658	ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]	19	Current NDC, Legacy NDC, 7 package rows	20230518_5a81a39b-051b-414e-a6b0-d844de4e9ab4.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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40d9cc46-aced-4866-812b-7d82933596ae	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0ea2c-0788-4e8a-e053-2a95a90a2f32	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0cd50-aa4f-55bc-e053-2995a90a2d3a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Advanced Rx of Tennessee, LLC	2a8603a9-5b6f-b921-e063-6394a90ae29c	2024-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	146b21e6-f8a5-47eb-b2d9-9ed70d1501d9	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078152 application number: ANDA078152

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	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	5a81a39b-051b-414e-a6b0-d844de4e9ab4	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1658-0	50090165800	1 BLISTER PACK in 1 PACKET (50090-1658-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2015-01-23	0000-00-00	No	No	Current
50090-1658-1	50090165801	1 BLISTER PACK in 1 PACKET (50090-1658-1) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2015-01-23	0000-00-00	No	No	Current
50090-1658-2	50090165802	1 BLISTER PACK in 1 PACKAGE (50090-1658-2) / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2015-01-23		No	No	Current
50090-1658-3	50090165803	30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (50090-1658-3)		2017-01-16	0000-00-00	No	No	Current