NDC Code(s) : 68788-8387-3, 68788-8387-6
Packager : Preferred Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EszopicloneEszopiclone TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8387(NDC:68462-382)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESZOPICLONE(UNII: UZX80K71OE)
(ESZOPICLONE - UNII:UZX80K71OE) 		ESZOPICLONE1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 382;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-8387-330 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
2NDC:68788-8387-660 in 1 BOTTLE Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091166 03/01/2023

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8387)

PRINCIPAL DISPLAY PANEL

1 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL

NDC 68788-8387

Eszopiclone Tablets, USP 1 mg C-IV

Eszopiclone Tablets 1mg