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
45558f0a-83f1-49b9-ab18-f436c0be9677
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
Products 1
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 Code68788-7667
Application NumberANDA208451
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESZOPICLONE
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (10)
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT