Primidone
Primidone Tablets, USP Anticonvulsant
Approved
Approval ID
3e081b24-20f5-4ffd-b493-771fd4ac2c96
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2018
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 Code71610-079
Application NumberANDA040586
Product Classification
M
Marketing Category
C73584
G
Generic Name
primidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2018
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PRIMIDONEActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB