Duloxetine Hydrochloride

Product NDC

55700-435

11-digit product format

557000435

Labeler code

55700

Product ID

55700-435_09c6b12a-008a-4f5f-a6f3-30e1bd0d2533

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetine Hydrochloride

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA202045

Marketing category

ANDA

Marketing start

2014-08-20

Marketing end

0000-00-00

Substance

DULOXETINE HYDROCHLORIDE

Active strength

20 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

2020-12-31

Current FDA listing

Historical FDA.report record