Flecainide Acetate
Flecainide Acetate Tablets, USP (50 mg, 100 mg and 150 mg) Rx only
Approved
Approval ID
ee9595d5-08a1-4529-9215-ddc3c7f929c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code53746-642
Application NumberANDA075442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (1)
FLECAINIDE ACETATEActive
Quantity: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-643
Application NumberANDA075442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (1)
FLECAINIDE ACETATEActive
Quantity: 150 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-641
Application NumberANDA075442
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (1)
FLECAINIDE ACETATEActive
Quantity: 50 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB