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

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 Identifiers#

Field, Values table
Field	Values
Unii	NMH84OZK2B
Rxcui	312085

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

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	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

Ondansetron

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#