Ondansetron

Product NDC: 0641-6078
11-digit product format: 006416078
Labeler code: 0641
Product ID: 0641-6078_9e948e67-37a3-48ca-ae91-a73efea950aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA077541
Marketing category: ANDA
Marketing start: 2006-12-26
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	2 mg/mL

Field, Values table
Field	Values
Unii	NMH84OZK2B
Rxcui	283504, 1740467

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6078-01	Ondansetron	2 mL in 1 VIAL	INJECTION	2		17
0641-6078-25	Ondansetron	25 in 1 CARTON	INJECTION	25		17

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6078-01	ML - Milliliter	0641-6078	9c323cc7-6ae6-410e-9b37-49f2dba28825	1	2012-07-24
0641-6078-25	ML - Milliliter	0641-6078	6303a3b5-0d5c-4f77-840a-dcf4dfa89724	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [CARDINAL HEALTH]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [CARDINAL HEALTH]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6078	ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 2 package rows	20240411_c29ca6df-621d-44b6-98fc-b48666573366.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283504	ondansetron 2 MG/ML Injectable Solution	PSN	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	ondansetron 4 MG in 2 ML Injection	PSN	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	c29ca6df-621d-44b6-98fc-b48666573366	17
283504	ondansetron 2 MG/ML Injectable Solution	SCD	c29ca6df-621d-44b6-98fc-b48666573366	17
283504	ondansetron (as ondansetron HCl ) 2 MG/ML Injectable Solution	SY	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	ondansetron 4 MG per 2 ML Injection	SY	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	ondansetron 4 MG in 2 ML Injection	PSN	61758670-91ab-4422-8d9d-e8ca87eecae8	9
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	61758670-91ab-4422-8d9d-e8ca87eecae8	9
1740467	ondansetron 4 MG per 2 ML Injection	SY	61758670-91ab-4422-8d9d-e8ca87eecae8	9
1740467	ondansetron 4 MG in 2 ML Injection	PSN	768aa02b-8231-5799-e053-2a91aa0a618d	7
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	768aa02b-8231-5799-e053-2a91aa0a618d	7
1740467	ondansetron 4 MG per 2 ML Injection	SY	768aa02b-8231-5799-e053-2a91aa0a618d	7
1740467	ondansetron 4 MG in 2 ML Injection	PSN	70bf93bc-e979-f080-e053-2991aa0a21df	3
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	70bf93bc-e979-f080-e053-2991aa0a21df	3
1740467	ondansetron 4 MG per 2 ML Injection	SY	70bf93bc-e979-f080-e053-2991aa0a21df	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6078-01	00641607801	2 mL in 1 VIAL	2 ml					Historical
0641-6078-25	00641607825	25 VIAL in 1 CARTON (0641-6078-25) / 2 mL in 1 VIAL (0641-6078-01)	25 vial	2006-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ondansetron	Hikma Pharmaceuticals USA Inc.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	17
Ondansetron	Cardinal Health 107, LLC	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	9
ONDANSETRON INJECTION, USP 4mg/2mL (2mg/mL) VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	7
Ondansetron	Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	3