Ondansetron

Product NDC: 71335-1071
Requested package NDC: 71335-1071-0
11-digit product format: 713351071
Labeler code: 71335
Product ID: 71335-1071_1f46e4a9-ad67-4deb-9c21-e3b2452a16ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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	71335-1071	71335-1071-0	D	Discontinued by firm		2026-10-05

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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090469-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090469-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090469-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090469-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090469-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090469-002	AB	1	`caaa826d4ba7…`
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…`

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: 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
d9321ef6-9fe5-4631-9c58-534fd963cf17	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9bd4853-037c-6968-f4d4-9bb9a0efd1ea	Product name	2	20250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1071-0	Ondansetron	3 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	3	104
71335-1071-1	Ondansetron	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	104
71335-1071-2	Ondansetron	10 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	10	104
71335-1071-3	Ondansetron	5 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	5	104
71335-1071-4	Ondansetron	4 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	4	104
71335-1071-5	Ondansetron	6 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	6	104
71335-1071-6	Ondansetron	14 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	14	104
71335-1071-7	Ondansetron	60 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	60	104
71335-1071-8	Ondansetron	12 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	12	104
71335-1071-9	Ondansetron	90 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	90	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1071-1	EA - Each	71335-1071	c02deed1-f895-4ef3-af81-70f200d2f260	1	2022-04-06
71335-1071-2	EA - Each	71335-1071	532a6640-3035-4b11-b1bc-ae4ba3863e34	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1071	ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 10 package rows	20240809_d9321ef6-9fe5-4631-9c58-534fd963cf17.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	Asclemed USA, Inc.	269c920c-643a-4eea-9bf9-b1f008915db9	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	66ac9c17-bea7-4f8d-8a27-a1e0f9e65945	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	70b48280-ef74-472b-abc3-128962bfcb05	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
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	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1071-0	71335107100	3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-0)	2022-05-02	0000-00-00	No	No	Current