Duloxetine

Product NDC

42292-020

11-digit product format

422920020

Labeler code

42292

Product ID

42292-020_7ef8ebd0-f005-850d-e053-2a91aa0aa1d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetine Hydrochloride

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA090778

Marketing category

ANDA

Marketing start

2016-12-13

Marketing end

2019-07-31

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