duloxetine
Approved
Approval ID
bcd11524-8111-5c7f-e053-2995a90a457a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2021
Manufacturers
FDA
Central Packaging
DUNS: 117617671
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
duloxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80175-0582
Application NumberANDA204343
Product Classification
M
Marketing Category
C73584
G
Generic Name
duloxetine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2021
FDA Product Classification
INGREDIENTS (1)
DULOXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 9044SC542W
Classification: ACTIM