ESZOPICLONE
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, CIV Initial U.S. Approval: 2004
Approved
Approval ID
33bc1c5f-c8cf-4c91-ad78-89d1d68d245d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2022
Manufacturers
FDA
OrchidPharma Inc
DUNS: 809429207
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESZOPICLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42043-321
Application NumberANDA091113
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (9)
ESZOPICLONEActive
Quantity: 2 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ESZOPICLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42043-320
Application NumberANDA091113
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (11)
ESZOPICLONEActive
Quantity: 1 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
ESZOPICLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42043-322
Application NumberANDA091113
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (11)
ESZOPICLONEActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT