Ondansetron

Product NDC: 53217-382
11-digit product format: 532170382
Labeler code: 53217
Product ID: 53217-382_0af47b75-6c82-4cc4-9f85-df9122faed16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090469
Marketing category: ANDA
Marketing start: 2018-06-15
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-382		I	Inactivated by FDA		2026-08-03
excluded package	package	53217-382	53217-382-10	I	Inactivated by FDA		2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-382-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-382-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-382-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-382-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-382-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-382-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-382-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-382-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-382-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-382-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-382-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-382-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-382-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-382-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-382-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-382-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-382-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-382-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-382-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-382-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-382-10	`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
A090469-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-04-12
A090469-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2010-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090469-001	AB
A090469-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

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

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-382-10	2020-01-31	C162847	48780-1	9d75b9d0-6265-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-382-10	Ondansetron	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-382	ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180825_a0ba2015-66cd-4c85-825f-e5db642ef95f.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	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	Sportpharm LLC	3c4cda2f-13d9-42c5-b449-77deb06c8de5	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	9dff6676-e69e-779d-e053-2995a90a7c81	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	76666e7e-3312-6f9d-e053-2991aa0af705	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f2b502e2-03ed-fe5c-e053-2995a90a368e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	db9a0d22-9339-4319-e053-2a95a90a9592	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	e07c38c0-e1c2-01de-e053-2995a90a390a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	9558d296-8edd-4aa1-875a-6247f9a8374d	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	10afd68b-877f-4819-a314-39f2d56d5db9	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	66ac9c17-bea7-4f8d-8a27-a1e0f9e65945	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	70b48280-ef74-472b-abc3-128962bfcb05	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469
Ondansetron	ONDANSETRON	Rising Pharma Holdings, Inc.	eb74425c-c635-4d99-8e98-e63e7359fb89	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090469 application number: ANDA090469

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	a0ba2015-66cd-4c85-825f-e5db642ef95f	1
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	a0ba2015-66cd-4c85-825f-e5db642ef95f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-382-10	53217038210	10 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-24	HUMAN PRESCRIPTION DRUG LABEL	1