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FDA Product

Ondansetron

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ondansetron

68071-4911

Regulatory Information

68071-4911

ANDA091342

C73584

February 18, 2021

USA

These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. for oral use Initial U.S. Approval: 1991

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

010632300

Active Ingredients

ONDANSETRON HYDROCHLORIDE

Quantity: 4 mg in 5 mL

Code: NMH84OZK2B

Class Code: ACTIM

Inactive Ingredients

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

ONDANSETRON

Code: 4AF302ESOS

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