ONDANSETRON

Product NDC: 63304-347
11-digit product format: 633040347
Labeler code: 63304
Product ID: 63304-347_1b169f76-a9a5-4704-a81c-094b497217a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Rnabaxy Pharmaceuticals Inc.
Application: ANDA078602
Marketing category: ANDA
Marketing start: 2012-01-10
Marketing end: 0000-00-00
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-347		I	Inactivated by FDA	2026-10-15
excluded package	package	63304-347	63304-347-05	I	Inactivated by FDA	2026-10-15
excluded package	package	63304-347	63304-347-30	I	Inactivated by FDA	2026-10-15
excluded package	package	63304-347	63304-347-69	I	Inactivated by FDA	2026-10-15

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 2 · 84 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	63304-347-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-347-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-347-69	`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	63304-347-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-347-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-347-69	`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	63304-347-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-347-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-347-69	`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	63304-347-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-347-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-347-69	`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	63304-347-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-347-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-347-69	`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	63304-347-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-347-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-347-69	`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	63304-347-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-347-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-347-69	`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	63304-347-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-347-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-347-69	`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	63304-347-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-347-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-347-69	`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	63304-347-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-347-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-347-69	`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	63304-347-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-347-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-347-69	`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	63304-347-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-347-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-347-69	`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	63304-347-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-347-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-347-69	`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	63304-347-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-347-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-347-69	`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	63304-347-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-347-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-347-69	`1332a3947898…`	`d4bfe170f9cd…`

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
A078602-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL			2011-02-24
A078602-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL			2011-02-24

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	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078602-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078602-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078602-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078602-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078602-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078602-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078602-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078602-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078602-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078602-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078602-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078602-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078602-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078602-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078602-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078602-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078602-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078602-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078602-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078602-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078602-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078602-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078602-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078602-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A078602-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078602-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078602-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078602-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078602-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078602-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078602-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078602-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078602-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078602-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078602-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078602-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078602-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078602-002	AB	1	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

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
63304-347-05	2020-01-31	C162847	48780-1	9d75b9d0-a282-f424-e053-dadaa90a57ce	PRESCRIBING INFORMATION ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP Rx only
63304-347-30	2020-01-31	C162847	48780-1	9d75b9d0-a282-f424-e053-dadaa90a57ce	PRESCRIBING INFORMATION ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP Rx only
63304-347-69	2020-01-31	C162847	48780-1	9d75b9d0-a282-f424-e053-dadaa90a57ce	PRESCRIBING INFORMATION ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63304-347-05	ONDANSETRON	500 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	500	3
63304-347-11	ONDANSETRON	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	3
63304-347-30	ONDANSETRON	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	3
63304-347-69	ONDANSETRON	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON	ACTIVE INGREDIENT	4AF302ESOS	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-347	ONDANSETRON (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [RNABAXY PHARMACEUTICALS INC.]	3	Legacy NDC, 4 package rows	20140116_69017f9f-1815-46d2-8e40-71cad10fa9d1.zip

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	69017f9f-1815-46d2-8e40-71cad10fa9d1	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	PSN	69017f9f-1815-46d2-8e40-71cad10fa9d1	3
104894	ondansetron 4 MG Disintegrating Oral Tablet	SCD	69017f9f-1815-46d2-8e40-71cad10fa9d1	3
312087	ondansetron 8 MG Disintegrating Oral Tablet	SCD	69017f9f-1815-46d2-8e40-71cad10fa9d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63304-347-05	63304034705	500 in 1 BOTTLE	Historical
63304-347-11	63304034711	10 in 1 BLISTER PACK	Historical
63304-347-30	63304034730	30 in 1 BOTTLE	Historical
63304-347-69	63304034769	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP Rx only	Rnabaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc. \| Qilu Pharmaceutical Company, Ltd.	2014-01-06	HUMAN PRESCRIPTION DRUG LABEL	3