Amiodarone Hydrochloride: Package Insert and Label Information

AMIODARONE HYDROCHLORIDE — amiodarone hydrochloride tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-631-14 in bottle of 60 tablets

Amiodarone Hydrochloride Tablets, 200 mg

Rx only

Amiodarone Hydrochloride Tablets, 200 mg
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AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-631
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code ZE;65
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-631-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-631-14 60 TABLET in 1 BOTTLE None
3 NDC:65841-631-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-631-10 1000 TABLET in 1 BOTTLE None
5 NDC:65841-631-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-631-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079029 08/10/2009
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-631), MANUFACTURE (65841-631)

Revised: 08/2022 Zydus Lifesciences Limited

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