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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-763
Application NumberANDA084903
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
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