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FDA Approval

Eszopiclone

CompanyLupin Pharmaceuticals, Inc. (DUNS: 089153071)

Effective Date

January 17, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Eszopiclone(2 mg in 1 1)

Registrants (1)

DUNS Number

675923163

Manufacturing Establishments (1)

Labeler

Lupin Pharmaceuticals, Inc.

Registrant

LUPIN LIMITED

DUNS Number

677600414

Products (3)

Eszopiclone

NDC Product Code

68180-323

Application Number

ANDA091124

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2024

Ingredients

EszopicloneActive

Code: UZX80K71OEClass: ACTIBQuantity: 2 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Eszopiclone

NDC Product Code

68180-322

Application Number

ANDA091124

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2024

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

EszopicloneActive

Code: UZX80K71OEClass: ACTIBQuantity: 1 mg in 1 1

Eszopiclone

NDC Product Code

68180-324

Application Number

ANDA091124

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2024

Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

EszopicloneActive

Code: UZX80K71OEClass: ACTIBQuantity: 3 mg in 1 1

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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