Primidone
Primidone Tablets, USP
Approved
Approval ID
ad8b50e2-e797-4326-a57e-d254da85b6b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Primidone
PRODUCT DETAILS
NDC Product Code71610-763
Application NumberANDA084903
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NamePrimidone
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLCELLULOSE (400 CPS)Inactive
Code: O0GN6F9B2Y
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PRIMIDONEActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB