ONDANSETRON
ONDANSETRON 4mg
Approved
Approval ID
91e36582-758e-49d2-e053-2995a90a6f7b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2023
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
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 Code61919-565
Application NumberANDA078539
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT