Primidone
and
Approved
Approval ID
5cada846-cb68-4d38-b42d-29167debabb7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4083
Application NumberANDA040866
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (1)
PRIMIDONEActive
Quantity: 250 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB