Ondansetron

Product NDC: 0409-2271
11-digit product format: 004092271
Labeler code: 0409
Product ID: 0409-2271_e0862c02-781f-4b10-ae50-9c9c4ca26f6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA077548
Marketing category: ANDA
Marketing start: 2025-12-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2006-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077548-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077548-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077548-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077548-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077548-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077548-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077548-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077548-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077548-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077548-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077548-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077548-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077548-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077548-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077548-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077548-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077548-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077548-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077548-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077548-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077548-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077548-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077548-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077548-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077548-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077548-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077548-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077548-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077548-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077548-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077548-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077548-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077548-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077548-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077548-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077548-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077548-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077548-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077548-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077548-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077548-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077548-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ondansetron
Listing expiration: 2026-12-31

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
e0862c02-781f-4b10-ae50-9c9c4ca26f6d	Available on FDA.report

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
0409-2271-02	Ondansetron	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1
0409-2271-25	Ondansetron	25 in 1 TRAY	INJECTION, SOLUTION	25		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-2271-02	ML - Milliliter	0409-2271	811639be-d865-43df-8a52-97adeaed63a4	1	2026-01-08
0409-2271-25	ML - Milliliter	0409-2271	8bd78f87-4d81-4353-ab42-18a073a885db	1	2026-01-08

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	1b9c2d9f-62a8-4d26-a041-a598bc59e300	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548
Ondansetron	ONDANSETRON	Hospira, Inc.	d62cd60b-f87e-4825-bead-1d18bbc4e480	2026-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548
Ondansetron	ONDANSETRON	Hospira, Inc.	6a11f61b-2318-4382-2b91-4366e4bb53fa	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548
Ondansetron	ONDANSETRON	Hospira, Inc.	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548 ndc (product): 0409-2271
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	99ac0a5e-dd2a-4352-e053-2a95a90a68fd	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548
Ondansetron	ONDANSETRON	Medical Purchasing Solutions, LLC	89698ef8-62d3-77e4-e053-2995a90ab9db	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077548 application number: ANDA077548

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1740467	ondansetron 4 MG in 2 ML Injection	PSN	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	1
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	1
1740467	ondansetron 4 MG per 2 ML Injection	SY	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0409-2271-02	00409227102	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical
0409-2271-25	00409227125	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-2271-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2271-02)		2025-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Hospira, Inc. \| Pfizer Healthcare India Private Limited	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	1