Eszopiclone
Eszopiclone 3mg Tablets
Approved
Approval ID
af86b753-d2ee-9b5f-e053-2a95a90ad23d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 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 Code80425-0067
Application NumberANDA091024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (1)
ESZOPICLONEActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB