Amiodarone Hydrochloride (Page 6 of 6)

AMIODARONE HYDROCHLORIDE TABLET

AMIODARONE HYDROCHLORIDE TABLET
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AMIODARONE HYDROCHLORIDE amiodarone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-051(NDC:68382-227)
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, UNSPECIFIED
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:63739-051-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX (63739-051-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079029 08/10/2009
Labeler — McKesson Corporation dba SKY Packaging (140529962)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 repack (63739-051), relabel (63739-051)

Revised: 03/2021 McKesson Corporation dba SKY Packaging

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