ONDANSETRON

Basic Information

Product Name

ONDANSETRON

FDA Product Code

76045-216

Regulatory Information

NDC Product Code

76045-216

Application Number

ANDA202253

Marketing Category

C73584

Effective Date

January 5, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ONDANSETRON INJECTION safely and effectively. See full prescribing information for ONDANSETRON INJECTION, USP. ONDANSETRON injection for intravenous or intramuscular use Initial U.S. Approval: 1991Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

ONDANSETRON HYDROCHLORIDE

Quantity: 4 mg in 2 mL

Code: NMH84OZK2B

Class Code: ACTIM

Active Moieties

Code: 4AF302ESOS

ONDANSETRON

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM CHLORIDE

CITRIC ACID MONOHYDRATE

TRISODIUM CITRATE DIHYDRATE

WATER

Active Moieties

ONDANSETRON