Flecainide Acetate
Flecainide Acetate Tablets USPRx only
Approved
Approval ID
5a12889a-52ce-4dc4-9240-22d126f071ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 3
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 Code62559-382
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: 150 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
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Flecainide Acetate Tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-380
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Flecainide Acetate Tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-381
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: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT