Zarontin
Zarontin (Ethosuximide) ORAL SOLUTION
Approved
Approval ID
7bf3e616-45e8-4469-a75d-4d824ce951ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Parke-Davis Div of Pfizer Inc
DUNS: 829076962
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ethosuximide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-2418
Application NumberANDA080258
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethosuximide
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2023
FDA Product Classification
INGREDIENTS (10)
ETHOSUXIMIDEActive
Quantity: 250 mg in 5 mL
Code: 5SEH9X1D1D
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT