Duloxetine

Product NDC

0093-7543

11-digit product format

000937543

Labeler code

0093

Product ID

0093-7543_b5adb19b-9a12-402f-8df8-d674920aa7f7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetine

Dosage form

CAPSULE, DELAYED RELEASE PELLETS

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA090783

Marketing category

ANDA

Marketing start

2013-12-11

Marketing end

2019-10-31

Substance

DULOXETINE HYDROCHLORIDE

Active strength

30 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record