Flecainide Acetate
FLECAINIDE ACETATE TABLETS, USP
Approved
Approval ID
fa68b35e-9f50-408b-9e70-e84cecf3fd6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2012
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flecainide
PRODUCT DETAILS
NDC Product Code63304-796
Application NumberANDA076421
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2012
Generic NameFlecainide
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
FLECAINIDE ACETATEActive
Quantity: 150 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
Flecainide
PRODUCT DETAILS
NDC Product Code63304-795
Application NumberANDA076421
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2012
Generic NameFlecainide
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FLECAINIDE ACETATEActive
Quantity: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Flecainide
PRODUCT DETAILS
NDC Product Code63304-794
Application NumberANDA076421
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2012
Generic NameFlecainide
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FLECAINIDE ACETATEActive
Quantity: 50 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT