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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-796
Application NumberANDA076421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-795
Application NumberANDA076421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-794
Application NumberANDA076421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
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