ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride Tablets
Approved
Approval ID
c5378585-dd35-4123-82b9-91395b56c3eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ONDANSETRON HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-834
Application NumberANDA077050
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2009
FDA Product Classification
INGREDIENTS (8)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ONDANSETRON HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-835
Application NumberANDA077050
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2009
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT