Flecainide Acetate
Flecainide Acetate Tablets, USP Rx only
Approved
Approval ID
552ce99a-1195-4f53-971a-ad5874bba9d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-2233
Application NumberANDA202821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flecainide Acetate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2020
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