ondansetron hydrochloride

Product NDC: 63629-4023
11-digit product format: 636294023
Labeler code: 63629
Product ID: 63629-4023_d9d5dd5d-6101-46bf-ac11-b105f625c78c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077050
Marketing category: ANDA
Marketing start: 2007-06-25
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4023		D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-0	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-3	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-4	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-5	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-6	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-7	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-8	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4023	63629-4023-9	D	Discontinued by firm	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 3 · 143 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	63629-4023-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4023-3	`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	63629-4023-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4023-3	`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	63629-4023-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4023-3	`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	63629-4023-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4023-3	`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	63629-4023-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4023-3	`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	63629-4023-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4023-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4023-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4023-6	`cdf11ea48f46…`	`ba0047e9e063…`

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
A077050-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL			2007-06-25
A077050-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL			2007-06-25

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	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL		2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077050-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077050-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077050-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077050-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077050-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077050-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077050-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077050-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077050-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077050-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077050-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077050-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077050-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077050-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077050-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077050-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077050-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077050-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077050-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077050-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077050-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077050-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077050-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077050-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077050-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077050-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077050-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077050-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077050-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077050-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077050-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077050-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077050-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077050-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077050-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077050-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077050-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077050-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077050-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077050-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077050-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077050-002	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4023-0	2020-07-21	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
63629-4023-1	2020-07-21	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
63629-4023-2	2020-07-21	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
63629-4023-3	2020-07-21	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
63629-4023-4	2020-07-21	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
63629-4023-5	2020-07-21	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
63629-4023-6	2020-07-21	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
63629-4023-7	2020-07-21	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
63629-4023-8	2020-07-21	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
63629-4023-9	2020-07-21	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
63629-4023-0	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
63629-4023-1	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
63629-4023-2	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
63629-4023-3	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
63629-4023-4	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
63629-4023-5	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
63629-4023-6	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
63629-4023-7	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
63629-4023-8	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
63629-4023-9	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4023-0	EA - Each	63629-4023	f3bebb9d-8a57-49f9-899c-e7309b126281	1	2023-09-05
63629-4023-1	EA - Each	63629-4023	c7a00f3f-0686-4736-87cb-4abd4a9c0508	1	2012-07-24
63629-4023-2	EA - Each	63629-4023	0c9a2ce0-927a-458d-831f-f71d1e0a897c	1	2012-07-24
63629-4023-3	EA - Each	63629-4023	69a1b2cc-e6ed-484f-b2e2-edbce2cd6e50	1	2012-07-24
63629-4023-4	EA - Each	63629-4023	2429504e-e192-41b0-b1f6-e98fa9802978	1	2012-07-24
63629-4023-5	EA - Each	63629-4023	2eb3bbde-fcad-4a7b-8f56-7c57e892c6b0	1	2013-02-13
63629-4023-6	EA - Each	63629-4023	fa719427-d7f1-4115-9353-4815714b0eb8	1	2013-02-13
63629-4023-7	EA - Each	63629-4023	8e850455-8a1b-4c56-9f06-4fa03412c649	1	2013-02-13
63629-4023-8	EA - Each	63629-4023	21c59a50-3e77-485c-9454-11d02dabfae0	1	2013-02-13
63629-4023-9	EA - Each	63629-4023	e3599d3e-b020-4bca-be85-6353276d6bd4	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077050 application number: ANDA077050

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4023-0	63629402300	60 TABLET, FILM COATED in 1 BOTTLE (63629-4023-0)	2009-06-19	0000-00-00	No	No	Current
63629-4023-1	63629402301	10 TABLET, FILM COATED in 1 BOTTLE (63629-4023-1)	2007-06-25	0000-00-00	No	No	Current
63629-4023-2	63629402302	3 TABLET, FILM COATED in 1 BOTTLE (63629-4023-2)	2007-06-25	0000-00-00	No	No	Current
63629-4023-3	63629402303	30 TABLET, FILM COATED in 1 BOTTLE (63629-4023-3)	2007-06-25	0000-00-00	No	No	Current
63629-4023-4	63629402304	15 TABLET, FILM COATED in 1 BOTTLE (63629-4023-4)	2007-06-25	0000-00-00	No	No	Current
63629-4023-5	63629402305	6 TABLET, FILM COATED in 1 BOTTLE (63629-4023-5)	2007-06-25	0000-00-00	No	No	Current
63629-4023-6	63629402306	4 TABLET, FILM COATED in 1 BOTTLE (63629-4023-6)	2007-06-25	0000-00-00	No	No	Current
63629-4023-7	63629402307	90 TABLET, FILM COATED in 1 BOTTLE (63629-4023-7)	2007-06-25	0000-00-00	No	No	Current
63629-4023-8	63629402308	12 TABLET, FILM COATED in 1 BOTTLE (63629-4023-8)	2007-06-25	0000-00-00	No	No	Current
63629-4023-9	63629402309	20 TABLET, FILM COATED in 1 BOTTLE (63629-4023-9)	2007-06-25	0000-00-00	No	No	Current