PRIMIDONE
PRIMIDONE TABLETS, USP 50 MG
Approved
Approval ID
ccadc401-fbcd-45e5-9c76-c8307324f638
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
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 Code42549-680
Application NumberANDA084903
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRIMIDONE
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2012
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PRIMIDONEActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT