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
NDC Product Code71610-079
Application NumberANDA040586
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 2, 2018
Generic Nameprimidone
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