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
7068c455-691e-4c56-9857-b7b4e13f4784
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-323
Application NumberANDA091124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
ESZOPICLONEActive
Quantity: 2 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Eszopiclone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-322
Application NumberANDA091124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESZOPICLONEActive
Quantity: 1 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
Eszopiclone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-324
Application NumberANDA091124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (12)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ESZOPICLONEActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT