Application 020403

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ONDANSETRON HYDROCHLORIDE	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1995-01-31

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML	INJECTABLE / INJECTION	RLD	1995-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML	INJECTABLE / INJECTION	RLD	1995-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020403-001	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`f41ea6bd6efb…`

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 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	960e2104-18c3-4cfa-abf6-f1b30c452918	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Major Pharmaceuticals	a29b5c18-9884-4c88-8827-65d9ad5f69f6	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	2026-08-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	5566aebb-d84d-6d6a-e063-6294a90a746f	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2a30d534-4607-4882-865e-56d2364acaad	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	14276805-4e99-4bbe-ad76-ffc06eddb38a	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	00b17a8e-9d38-a8d4-e063-6294a90a153e	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	0a14eb9a-0385-40e9-a7ec-71435450ac91	2026-08-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57b0a1e5-5dfa-64a0-e063-6394a90acf36	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Ipca Laboratories Limited	7ab3210e-eed1-479a-afc0-f72b5b776883	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Ascend Laboratories, LLC	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Cardinal Health 107, LLC	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	3f2e8efe-7fd4-407c-a77b-bd6dd04608e2	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	ee3e8cbe-4f0b-4361-a1b5-8329d85a2932	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	561dce26-92fa-e00b-e063-6294a90a1ab2	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	58f16a00-3e66-29de-e053-2991aa0a59a0	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	American Health Packaging	9f015e60-1aec-4ae7-b28f-42f6c8f50455	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Coupler LLC	546191d2-d092-6342-e063-6294a90a0cd3	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Redpharm Drug	541b9a0d-ae94-db6f-e063-6394a90a9805	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	c0be25a0-e13d-4242-93dc-0b86e82aadd7	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24914	SUPPL	2011-09-16
12540	SUPPL	2011-09-16
2483	SUPPL	2011-07-13
34605	SUPPL	2011-07-12
12539	SUPPL	2010-09-29
24913	SUPPL	2010-09-28
41338	SUPPL	2009-09-16
20634	SUPPL	2009-01-12
24912	SUPPL	2006-09-18
34604	SUPPL	2006-08-23
24911	SUPPL	2006-01-06
12538	SUPPL	2006-01-05
12537	SUPPL	2004-12-03
24910	SUPPL	2004-12-02
41337	SUPPL	1997-10-31