Flecainide Acetate (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

1
(click image for full-size original)
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 50 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code AN;641
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-641-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-641-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075442 12/01/2009
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 100 mg
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code AN;642
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-642-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-642-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075442 12/01/2009
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-643
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 150 mg
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code AN;643
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-643-01 100 TABLET in 1 BOTTLE None
2 NDC:53746-643-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075442 12/01/2009
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 915076126 analysis (53746-641), analysis (53746-642), analysis (53746-643), label (53746-641), label (53746-642), label (53746-643), manufacture (53746-641), manufacture (53746-642), manufacture (53746-643), pack (53746-641), pack (53746-642), pack (53746-643)

Revised: 12/2022 Amneal Pharmaceuticals of New York LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/flecainide-acetate-23/page/5/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.