Duloxetine
These highlights do not include all the information needed to use duloxetine safely and effectively. See full prescribing information for duloxetine. Duloxetine Delayed-Release Capsules for Oral Use. Initial U.S. Approval: 2004
Approved
Approval ID
7f1c4bec-1cf4-4d10-8c9c-7615fa8f9fae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2014
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Duloxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-4727
Application NumberNDA021427
Product Classification
M
Marketing Category
C73605
G
Generic Name
Duloxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2014
FDA Product Classification
INGREDIENTS (11)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Duloxetine hydrochlorideActive
Quantity: 60 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)Inactive
Code: 24P2YXD2PW
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT