Primidone
Primidone Tablets USP
Approved
Approval ID
a4f917f4-2aa2-c3ed-071e-232fa0f125e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2010
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
Products 2
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 Code55111-477
Application NumberANDA040862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2010
FDA Product Classification
INGREDIENTS (7)
primidoneActive
Quantity: 50 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Primidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-476
Application NumberANDA040862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Primidone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2010
FDA Product Classification
INGREDIENTS (8)
primidoneActive
Quantity: 250 mg in 1 1
Code: 13AFD7670Q
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/8/2010
Anticonvulsant