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INJECTABLE;INJECTION	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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ONDANSETRON HYDROCHLORIDE	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1995-01-31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AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`84e616aacf4f…`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AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`caaa826d4ba7…`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AND DEXTROSE IN PLASTIC CONTAINER	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-01-31	`011fe1cb6892…`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 4 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	Bryant Ranch Prepack	3aeb533a-e72c-4af8-9867-b71d2eba9a49	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	115e8fb5-61f5-4719-8eb3-063b7ca194ae	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	d6694136-7591-4f23-8415-f2aa3c8bab40	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b406d22-f1bf-460d-e063-6294a90a6b6f	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	91bfbc0e-86a3-8ac6-e053-2a95a90af432	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NUCARE PHARMACEUTICALS INC	8d696b8c-eba6-505e-e053-2995a90acb5d	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7f315229-7e8f-67fd-e053-2a91aa0a8cb6	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	67395789-0ac7-2244-e053-2a91aa0a652a	2024-06-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	00327696-c496-4c83-a63e-9e29fd6246d4	2024-04-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Eugia US LLC	1cc94c7a-617c-4238-8248-e3fabc9612c7	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	6a231919-6837-4b09-b66d-3706432b9702	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0050959-c14c-41b6-9a92-fadc5f6feff3	2023-11-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	674ea285-8f84-4603-9655-82200c523fe5	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	d89017aa-b8c3-4fd2-8e68-44e2cfd6f290	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	65f01335-452e-42c6-a59b-4eb03badc55a	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	f8f371c7-09f8-426c-ae22-753cd5626da3	2023-01-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Pharmpak, Inc.	e41b9469-e844-47d9-933a-4c9f4453ecc7	2022-10-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	69ed01b7-a94e-4946-a044-a9f8c37616ec	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4	2022-04-01	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