Duloxetine Hydrochloride

Product NDC

0615-8035

11-digit product format

006158035

Labeler code

0615

Product ID

0615-8035_a445e86b-e120-4b61-96b6-bb49075a7057

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetine Hydrochloride

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA202045

Marketing category

ANDA

Marketing start

2014-06-13

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