Eszopiclone
Eszopiclone 1mg Tablets
Approved
Approval ID
c8ae09eb-4c9b-4560-e053-2995a90a02b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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 Code80425-0168
Application NumberANDA202929
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2023
FDA Product Classification
INGREDIENTS (1)
ESZOPICLONEActive
Quantity: 1 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB