Duloxetine hydrochloride

Product NDC

0615-7895

11-digit product format

006157895

Labeler code

0615

Product ID

0615-7895_33f15a34-eeda-412e-b53a-a184922e0676

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetin hydrochloride

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA090774

Marketing category

ANDA

Marketing start

2013-12-11

Marketing end

0000-00-00

Substance

DULOXETINE HYDROCHLORIDE

Active strength

60 mg/1

Pharmacologic classes

Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record