ONDANSETRON
Ondansetron Orally Disintegrating Tablets
Approved
Approval ID
6c450150-a7a4-46f3-b62a-848eeefada06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2011
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-097
Application NumberANDA077557
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2009
FDA Product Classification
INGREDIENTS (8)
ONDANSETRONActive
Quantity: 8 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GLYCERYL DISTEARATEInactive
Code: 73071MW2KM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ONDANSETRON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-077
Application NumberANDA077557
Product Classification
M
Marketing Category
C73584
G
Generic Name
ONDANSETRON
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2009
FDA Product Classification
INGREDIENTS (8)
ONDANSETRONActive
Quantity: 4 mg in 1 1
Code: 4AF302ESOS
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GLYCERYL DISTEARATEInactive
Code: 73071MW2KM
Classification: IACT