Flecainide Acetate
Flecainide Acetate Tablets, USP Rx only
Approved
Approval ID
14e89448-3a18-42e3-8537-2589be1ef94e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-621
Application NumberANDA202821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
FLECAINIDE ACETATEActive
Quantity: 50 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-622
Application NumberANDA202821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
FLECAINIDE ACETATEActive
Quantity: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-623
Application NumberANDA202821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
FLECAINIDE ACETATEActive
Quantity: 150 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT