Lunesta
These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA (eszopiclone) tablets, for oral use, CInitial U.S. Approval: 2004
Approved
Approval ID
3821f4b7-a3c8-4920-ba80-18aa96532c09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
Waylis Therapeutics LLC
DUNS: 117678921
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 Code80725-010
Application NumberNDA021476
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ESZOPICLONEActive
Quantity: 1 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ESZOPICLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-011
Application NumberNDA021476
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (11)
ESZOPICLONEActive
Quantity: 2 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ESZOPICLONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-012
Application NumberNDA021476
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (12)
ESZOPICLONEActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT