Sotalol Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Sotalol HCL Tabs 80mg -- Apotex
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SOTALOL HYDROCHLORIDE
sotalol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7888(NDC:60505-0080)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTALOL HYDROCHLORIDE (SOTALOL) SOTALOL HYDROCHLORIDE 80 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code APO;SO;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7888-39 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076140 02/01/2003
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL (0615-7888), REPACK (0615-7888)

Revised: 09/2015 NCS HealthCare of KY, Inc dba Vangard Labs

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