Ondansetron

Product NDC: 70860-776
11-digit product format: 708600776
Labeler code: 70860
Product ID: 70860-776_e24e8318-7890-4329-8cdb-2133cf4c29bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA079224
Marketing category: ANDA
Marketing start: 2017-01-01
Marketing end: 0000-00-00
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70860-776		D	Discontinued by firm		2026-08-17
excluded package	package	70860-776	70860-776-02	D	Discontinued by firm		2026-08-17

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 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70860-776		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70860-776	70860-776-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A079224-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079224-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A079224-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079224-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	AP	1	`e64feba35796…`

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
70860-776-02	2024-03-04	C162847	48780-1	1030e365-68e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ONDANSETRON INJECTION safely and effectively. See full prescribing information for ONDANSETRON INJECTION. ONDANSETRON injection, for intravenous or intramuscular use Initial U.S. Approval: 1991
70860-776-02	2024-01-30	C162847	48780-1	1030e365-68e1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ONDANSETRON INJECTION safely and effectively. See full prescribing information for ONDANSETRON INJECTION. ONDANSETRON injection, for intravenous or intramuscular use 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
70860-776-02	ML - Milliliter	70860-776	cb58f9c6-34ca-4b95-b5cf-89a6f15c5513	1	2017-03-06
70860-776-41	ML - Milliliter	70860-776	d46ced69-c0d1-48e9-9c87-4d7ccd01a300	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-776	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	11	Legacy NDC	20240306_04e315ea-f820-4ae2-b237-ea5b8722fa9f.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b746d4db-43e6-4219-9e6b-f53e59581305	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
Ondansetron	ONDANSETRON	Gland Pharma Limited	3efa5604-96c3-42a0-8e99-b3de4a66aa92	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1740467	ondansetron 4 MG in 2 ML Injection	PSN	6a265130-d344-5744-e053-2a91aa0a8955	3
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	6a265130-d344-5744-e053-2a91aa0a8955	3
1740467	ondansetron 4 MG per 2 ML Injection	SY	6a265130-d344-5744-e053-2a91aa0a8955	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-776-02	70860077602	25 VIAL, SINGLE-DOSE in 1 CARTON (70860-776-02) > 2 mL in 1 VIAL, SINGLE-DOSE (70860-776-41)	2018-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Athenex Pharmaceutical Division, LLC.	2024-03-04	HUMAN PRESCRIPTION DRUG LABEL	11
Ondansetron	Medical Purchasing Solutions, LLC	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	3
Ondansetron	REMEDYREPACK INC.	2018-09-18	HUMAN PRESCRIPTION DRUG LABEL	1