Ondansetron Hydrochloride
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
Approved
Approval ID
71451add-9117-4512-83cd-08f153ce4a2f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 3, 2020
Manufacturers
FDA
Clinical Solutions Wholesale, LLC
DUNS: 078710347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron Hydrochloride
PRODUCT DETAILS
NDC Product Code58118-7500
Application NumberANDA078539
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 3, 2020
Generic NameOndansetron Hydrochloride
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM