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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5067
Application NumberANDA084903
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2013
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1691
Application NumberANDA084903
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2013
FDA Product Classification
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