Ondansetron

Product NDC: 55154-6976
11-digit product format: 551546976
Labeler code: 55154
Product ID: 55154-6976_e4af3b1a-81e8-41c0-a8b0-9ee07ab0d613
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Cardinal Health 107, LLC
Application: ANDA077548
Marketing category: ANDA
Marketing start: 2008-10-16
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 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: 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
1b9c2d9f-62a8-4d26-a041-a598bc59e300	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-6976-5	Ondansetron	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		13
55154-6976-5	Ondansetron	5 in 1 BAG	INJECTION, SOLUTION	5		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-6976	ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240319_1b9c2d9f-62a8-4d26-a041-a598bc59e300.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 · 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 ndc (product): 55154-6976
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
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	1b9c2d9f-62a8-4d26-a041-a598bc59e300	13
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	1b9c2d9f-62a8-4d26-a041-a598bc59e300	13
1740467	ondansetron 4 MG per 2 ML Injection	SY	1b9c2d9f-62a8-4d26-a041-a598bc59e300	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-6976-5	55154697605	5 VIAL, SINGLE-DOSE in 1 BAG (55154-6976-5) / 2 mL in 1 VIAL, SINGLE-DOSE	2008-10-16	0000-00-00	No	No	Current