Ondansetron Hydrochloride

Basic Information

Product Name

FDA Product Code

71335-1596

Regulatory Information

NDC Product Code

71335-1596

Application Number

ANDA078539

Marketing Category

C73584

Effective Date

February 25, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

ONDANSETRON HYDROCHLORIDE

Quantity: 4 mg in 1 1

Code: NMH84OZK2B

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

Active Moieties

ONDANSETRON

Code: 4AF302ESOS

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS LACTOSE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

STARCH, CORN

TRIACETIN

TITANIUM DIOXIDE

HYPROMELLOSE 2910 (6 MPA.S)

Active Moieties

ONDANSETRON