Primidone
PRIMIDONE TABLETS, USP
Approved
Approval ID
c7cb2073-9d44-4261-b308-02cd24c1f17a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Primidone
PRODUCT DETAILS
NDC Product Code54868-5067
Application NumberANDA084903
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 19, 2013
Generic NamePrimidone
INGREDIENTS (6)
PRIMIDONEActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
Primidone
PRODUCT DETAILS
NDC Product Code54868-1691
Application NumberANDA084903
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 19, 2013
Generic NamePrimidone
INGREDIENTS (6)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PRIMIDONEActive
Quantity: 250 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT