ZENPEP

Product NDC

42865-300

11-digit product format

428650300

Labeler code

42865

Product ID

42865-300_c7f326d9-a87f-4412-8429-daa379ae9585

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

pancrelipase

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Allergan, Inc.

Application

NDA022210

Marketing category

NDA

Marketing start

2009-09-22

Marketing end

2020-02-29

Substance

PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE

Active strength

5000 [USP'U]/1; [USP'U]/1; [USP'U]/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record