Primidone
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx Only
Approved
Approval ID
70b93341-ce93-4be5-a782-87c1a26129d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2021
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 Code71610-590
Application NumberANDA040586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2021
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PRIMIDONEActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT