PRUDOXIN

Product NDC

40076-511

11-digit product format

400760511

Labeler code

40076

Product ID

40076-511_86ce3555-6c42-4501-8e8b-aec84f0fef62

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

doxepin hydrochloride

Dosage form

CREAM

Route

TOPICAL

Labeler

Prestium Pharma, Inc.

Application

NDA020126

Marketing category

NDA

Marketing start

2015-06-01

Marketing end

2019-07-31

Substance

DOXEPIN HYDROCHLORIDE

Active strength

50 mg/g

Pharmacologic classes

Tricyclic Antidepressant [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record