Basic Information
Eszopiclone
68462-383
Regulatory Information
68462-383
ANDA091166
C73584
October 18, 2019
USA
These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE Tablets, for oral use, CIVInitial U.S. Approval: 2004
HUMAN PRESCRIPTION DRUG LABEL
10
Company Information
130597813
Active Ingredients
ANHYDROUS LACTOSE
Code: 3SY5LH9PMK
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Code: L11K75P92J
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
Active Moieties
ESZOPICLONE
Code: UZX80K71OE