Ondansetron

Product NDC: 16714-671
11-digit product format: 167140671
Labeler code: 16714
Product ID: 16714-671_add9275d-a837-48f4-ab0b-01fc50e4545f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA078776
Marketing category: ANDA
Marketing start: 2007-11-28
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/5mL
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-671	16714-671-01	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078776-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2007-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078776-001	AA

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	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078776-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-11-28	`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	A078776-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078776-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078776-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078776-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078776-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078776-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078776-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078776-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078776-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078776-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078776-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078776-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078776-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078776-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078776-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078776-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078776-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078776-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078776-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078776-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078776-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078776-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078776-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078776-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078776-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078776-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078776-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078776-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078776-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078776-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078776-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078776-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078776-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078776-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078776-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078776-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078776-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078776-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078776-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078776-001	AA	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	4 mg/5mL

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
312085	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
ac3dfb81-a4c7-4147-9374-c234153b7c51	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-671-01	Ondansetron	1 in 1 CARTON	SOLUTION	1	14
16714-671-01	Ondansetron	50 mL in 1 BOTTLE	SOLUTION	50	14
16714-671-02	Ondansetron	50 mL in 1 BOTTLE, PLASTIC	SOLUTION	50	14
16714-671-02	Ondansetron	1 in 1 CARTON	SOLUTION	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-671-01	ML - Milliliter	16714-671	f85fd36b-6b85-4724-a2e5-dbdcc978e0cd	1	2012-07-24
16714-671-02	ML - Milliliter	16714-671	1634201f-a898-4682-b817-79c812875277	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-671	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC]	13	Current NDC, Legacy NDC, 4 package rows	20240507_ac3dfb81-a4c7-4147-9374-c234153b7c51.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON HYDROCHLORIDE	Atlantic Biologics Corp.	41d71d26-0d42-b368-e063-6394a90add43	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078776 application number: ANDA078776
Ondansetron	ONDANSETRON HYDROCHLORIDE	NorthStar Rx LLC	ac3dfb81-a4c7-4147-9374-c234153b7c51	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078776 application number: ANDA078776 ndc (product): 16714-671
Ondansetron	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	cf10d256-dd89-4a91-a3ed-81db505a79c2	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078776 application number: ANDA078776
Ondansetron	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b406d22-f1bf-460d-e063-6294a90a6b6f	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078776 application number: ANDA078776

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
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	ac3dfb81-a4c7-4147-9374-c234153b7c51	14
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	ac3dfb81-a4c7-4147-9374-c234153b7c51	14
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	ac3dfb81-a4c7-4147-9374-c234153b7c51	14
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	ac3dfb81-a4c7-4147-9374-c234153b7c51	14
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	1b406d22-f1bf-460d-e063-6294a90a6b6f	1
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	41d71d26-0d42-b368-e063-6394a90add43	1
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	1b406d22-f1bf-460d-e063-6294a90a6b6f	1
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	41d71d26-0d42-b368-e063-6394a90add43	1
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	1b406d22-f1bf-460d-e063-6294a90a6b6f	1
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	41d71d26-0d42-b368-e063-6394a90add43	1
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	1b406d22-f1bf-460d-e063-6294a90a6b6f	1
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	41d71d26-0d42-b368-e063-6394a90add43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-671-01	16714067101	1 BOTTLE in 1 CARTON (16714-671-01) > 50 mL in 1 BOTTLE	1 bottle	2007-11-28	0000-00-00	No	No	Current
16714-671-02	16714067102	1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02) / 50 mL in 1 BOTTLE, PLASTIC		2007-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Atlantic Biologics Corp.	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron	NorthStar Rx LLC \| Aurobindo Pharma Limited	2025-08-11	Human Prescription Drug Label	14
Ondansetron	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	1