PANCREAZE

Product NDC

50458-346

11-digit product format

504580346

Labeler code

50458

Product ID

50458-346_84df27aa-7ea7-11e8-b709-c19a9d46d017

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

PANCRELIPASE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA022523

Marketing category

NDA

Marketing start

2010-04-12

Marketing end

2019-08-31

Substance

PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE

Active strength

21000 [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