Ondansetron Hydrochloride
Ondansetron Hydrochloride Tablets
Approved
Approval ID
93f6d82b-0594-4b48-9711-201d79a03315
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-991
Application NumberANDA077517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (9)
LACTOSE, ANHYDROUSInactive
Code: 3SY5LH9PMK
Classification: IACT
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: NMH84OZK2B
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT