Eszopiclone (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eszopiclone Tablets USP, 3 mg

Rx Only

43063795 Label
(click image for full-size original)
ESZOPICLONE eszopiclone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-795(NDC:68180-324)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESZOPICLONE (ESZOPICLONE) ESZOPICLONE 3 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 2
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color blue (dark blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LU;Y23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-795-30 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 ANDA091124 04/15/2014
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-795)

Revised: 08/2022 PD-Rx Pharmaceuticals, Inc.

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