Eszopiclone (Page 9 of 9)

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eszo
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ESZOPICLONE
eszopiclone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-526(NDC:68462-383)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESZOPICLONE (ESZOPICLONE) ESZOPICLONE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 383;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60760-526-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091166 06/07/2021
Labeler — St Mary’s Medical Park Phcy (063050751)
Establishment
Name Address ID/FEI Operations
St Mary’s Medical Park Pharmacy 063050751 repack (60760-526), relabel (60760-526)

Revised: 06/2021 St Mary’s Medical Park Phcy

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