Flecainide Acetate
Flecainide Acetate Tablets USPRx only
Approved
Approval ID
9929c166-8ba3-4159-a5f9-4618d5d227b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flecainide Acetate Tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9184
Application NumberANDA075882
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate Tablet
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2017
FDA Product Classification
INGREDIENTS (7)
FLECAINIDE ACETATEActive
Quantity: 50 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT