ONDANSETRON HYDROCHLORIDE

Product NDC: 36000-013
11-digit product format: 360000013
Labeler code: 36000
Product ID: 36000-013_1b04a14c-4bde-4379-b681-c1eda4d4451d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON HYDROCHLORIDE
Dosage form: SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA078288
Marketing category: ANDA
Marketing start: 2013-03-13
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: 2020-12-31
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	36000-013		D	Discontinued by firm		2026-10-05
excluded package	package	36000-013	36000-013-01	D	Discontinued by firm		2026-10-05

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 · 24 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	36000-013-01	`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	36000-013-01	`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	36000-013-01	`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	36000-013-01	`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	36000-013-01	`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	36000-013-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36000-013-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36000-013-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36000-013-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36000-013-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36000-013-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36000-013-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078288-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22

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	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078288-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-02-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078288-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078288-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078288-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078288-001	AP	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36000-013-01	ONDANSETRON HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		22
36000-013-01	ONDANSETRON HYDROCHLORIDE	20 mL in 1 VIAL	SOLUTION	20		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36000-013-01	ML - Milliliter	36000-013	c097bca7-7a2d-4660-a6b1-15b0ecde8fbd	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON HYDROCHLORIDE SOLUTION [CLARIS LIFESCIENCES INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36000-013	ONDANSETRON HYDROCHLORIDE SOLUTION [BAXTER HEALTHCARE CORPORATION]	20	Legacy NDC, 2 package rows	20240921_729d865f-d84a-495e-9456-4bceebb6e03f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	Baxter Healthcare Corporation	729d865f-d84a-495e-9456-4bceebb6e03f	2025-06-30	Warnings, Adverse reactions	Exact identifier ndc (product): 36000-013

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
283504	ondansetron 2 MG/ML Injectable Solution	PSN	729d865f-d84a-495e-9456-4bceebb6e03f	22
1740467	ondansetron 4 MG in 2 ML Injection	PSN	729d865f-d84a-495e-9456-4bceebb6e03f	22
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	729d865f-d84a-495e-9456-4bceebb6e03f	22
283504	ondansetron 2 MG/ML Injectable Solution	SCD	729d865f-d84a-495e-9456-4bceebb6e03f	22
283504	ondansetron (as ondansetron HCl ) 2 MG/ML Injectable Solution	SY	729d865f-d84a-495e-9456-4bceebb6e03f	22
1740467	ondansetron 4 MG per 2 ML Injection	SY	729d865f-d84a-495e-9456-4bceebb6e03f	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
36000-013-01	36000001301	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ONDANSETRON HYDROCHLORIDE	Baxter Healthcare Corporation \| BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	22