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 CIVInitial U.S. Approval: 2004
Approved
Approval ID
eb967d20-9a6d-4ccd-8618-22b87faa1d84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
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 Code43353-185
Application NumberANDA091151
Product Classification
M
Marketing Category
C73584
G
Generic Name
eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2016
FDA Product Classification
INGREDIENTS (12)
ESZOPICLONEActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
eszopiclone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-200
Application NumberANDA091151
Product Classification
M
Marketing Category
C73584
G
Generic Name
eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2016
FDA Product Classification
INGREDIENTS (12)
ESZOPICLONEActive
Quantity: 2 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT