ONDANSETRON

Product NDC: 85766-234
Requested package NDC: 85766-234-25
11-digit product format: 857660234
Labeler code: 85766
Product ID: 85766-234_559a67f6-acfd-9f58-e063-6394a90a0075
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sportpharm LLC
Application: ANDA203711
Marketing category: ANDA
Marketing start: 2016-05-26
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A203711-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203711-001	AP

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203711-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203711-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203711-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203711-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203711-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203711-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203711-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203711-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203711-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203711-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203711-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203711-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203711-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203711-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203711-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203711-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203711-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203711-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203711-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203711-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203711-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203711-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203711-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203711-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203711-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203711-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203711-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203711-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203711-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203711-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203711-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203711-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203711-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203711-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203711-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203711-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203711-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203711-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203711-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203711-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ONDANSETRON
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1740467	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
de72f1ec-75dd-4659-a1a0-32b28b72c799	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	1a44601b-c31c-4779-a688-28cc4cc75e8b	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	Sportpharm LLC	de72f1ec-75dd-4659-a1a0-32b28b72c799	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (package): 85766-234-25 ndc (product): 85766-234 ndc11 (package): 85766023425
ONDANSETRON	ONDANSETRON	A-S Medication Solutions	b60074e5-8e77-4dc0-9244-4205e4adbaef	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	ProPharma Distribution	3d5d25eb-8711-ef8c-e063-6394a90a5e03	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	Apotex Corp.	2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	Medical Purchasing Solutions, LLC	677b5fc5-9471-638b-e053-2991aa0a7f97	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	5e09e262-dadf-4ae0-825e-448ea8dac174	2022-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE
4AF302ESOS	ONDANSETRON	99614-02-5	ONDANSETRON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-234-25	85766023425	25 VIAL, SINGLE-USE in 1 CARTON (85766-234-25) / 2 mL in 1 VIAL, SINGLE-USE (85766-234-01)	2026-07-02	No	No	Current