Ondansetron
These highlights do not include all the information needed to use ONDANSETRON TABLETS, USP safely and effectively. See full prescribing information for ONDANSETRON TABLETS, USP. ONDANSETRON TABLETS USP, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
b68038d8-1579-4c7c-9ab5-63914798288d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2022
Manufacturers
FDA
Eywa Pharma Inc.
DUNS: 080465609
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71930-018
Application NumberANDA077851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2022
FDA Product Classification
INGREDIENTS (10)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71930-017
Application NumberANDA077851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2022
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT