Ondansetron

Product NDC: 65162-691
11-digit product format: 651620691
Labeler code: 65162
Product ID: 65162-691_7421d60d-7d82-4ec5-885a-255c507c32a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA091483
Marketing category: ANDA
Marketing start: 2010-12-17
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

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
A091483-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091483-001	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 · 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	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`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	A091483-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091483-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091483-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091483-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091483-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091483-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091483-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091483-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091483-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091483-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091483-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091483-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091483-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091483-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091483-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091483-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091483-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091483-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091483-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091483-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091483-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091483-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091483-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091483-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091483-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091483-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091483-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091483-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091483-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091483-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091483-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091483-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091483-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091483-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091483-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091483-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091483-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091483-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091483-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091483-001	AA	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	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
38435346-d505-4bdd-bbc6-a7bcba411033	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
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
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
65162-691-19	Ondansetron	10 in 1 TRAY	SOLUTION	10	26
65162-691-37	Ondansetron	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	26
65162-691-79	Ondansetron	50 mL in 1 BOTTLE	SOLUTION	50	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-691-79	ML - Milliliter	65162-691	48b2fbd9-f85a-44af-8eac-f06bf677760e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	7
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-691	ONDANSETRON SOLUTION [AMNEAL PHARMACEUTICALS LLC]	23	Current NDC, Legacy NDC, 3 package rows	20250207_38435346-d505-4bdd-bbc6-a7bcba411033.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	American Health Packaging	92b96072-e8f2-4fd6-aaa0-b73fed214319	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483
Ondansetron	ONDANSETRON	AvPAK	05cf8d4f-ac57-4177-e063-6394a90ae804	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483
Ondansetron	ONDANSETRON	Amneal Pharmaceuticals LLC	38435346-d505-4bdd-bbc6-a7bcba411033	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483 ndc (product): 65162-691
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483

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
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	38435346-d505-4bdd-bbc6-a7bcba411033	26
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	38435346-d505-4bdd-bbc6-a7bcba411033	26
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	38435346-d505-4bdd-bbc6-a7bcba411033	26
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	38435346-d505-4bdd-bbc6-a7bcba411033	26
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	e5ab38a2-5921-4320-a313-e0080c078046	15
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	e5ab38a2-5921-4320-a313-e0080c078046	15
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	e5ab38a2-5921-4320-a313-e0080c078046	15
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	e5ab38a2-5921-4320-a313-e0080c078046	15
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	92b96072-e8f2-4fd6-aaa0-b73fed214319	10
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	92b96072-e8f2-4fd6-aaa0-b73fed214319	10
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	92b96072-e8f2-4fd6-aaa0-b73fed214319	10
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	92b96072-e8f2-4fd6-aaa0-b73fed214319	10
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	7f60016c-7c84-4ffa-8adb-2688105b3054	2
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	7a3c9566-1847-4867-b528-0e91fb8bab94	2
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	7f60016c-7c84-4ffa-8adb-2688105b3054	2
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	7a3c9566-1847-4867-b528-0e91fb8bab94	2
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	7a3c9566-1847-4867-b528-0e91fb8bab94	2
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	7f60016c-7c84-4ffa-8adb-2688105b3054	2
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	7a3c9566-1847-4867-b528-0e91fb8bab94	2
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	7f60016c-7c84-4ffa-8adb-2688105b3054	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-691-19	65162069119	10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37)		2010-12-17		No	No	Current
65162-691-37	65162069137	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
65162-691-79	65162069179	50 mL in 1 BOTTLE (65162-691-79)	50 ml	2010-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	American Health Packaging	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	11
Ondansetron	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	26
Ondansetron	ATLANTIC BIOLOGICALS CORP.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	15
Ondansetron	Major Pharmaceuticals	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	6
Ondansetron	Lohxa	2021-02-25	HUMAN PRESCRIPTION DRUG LABEL	2
Ondansetron Oral Solution, USP 4 MG/5 ML	Atlantic Biologicals Corps	2011-06-10	HUMAN PRESCRIPTION DRUG LABEL	2