Flecainide Acetate
FLECAINIDE ACETATE Tablets, USP
Approved
Approval ID
89105dbf-1085-4c81-ab19-49c7b5966e7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5074
Application NumberANDA076278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (6)
FLECAINIDE ACETATEActive
Quantity: 50 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5405
Application NumberANDA076278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (6)
FLECAINIDE ACETATEActive
Quantity: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Flecainide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5586
Application NumberANDA076278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FLECAINIDE ACETATEActive
Quantity: 150 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT