Creon

Basic Information

Product Name

Creon

FDA Product Code

17856-1212

Regulatory Information

NDC Product Code

17856-1212

Application Number

NDA020725

Marketing Category

C73594

Effective Date

January 27, 2012

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CREON safely and effectively. See full prescribing information for CREON. CREON (pancrelipase) delayed-release capsules for oral use Initial U.S. Approval: 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PANCRELIPASE LIPASE

Quantity: 12000 [USP'U] in 1 1

Code: 8MYC33932O

Class Code: ACTIB

cetyl alcohol

Code: 936JST6JCN

Class Code: IACT

PANCRELIPASE AMYLASE

Quantity: 60000 [USP'U] in 1 1

Code: YOJ58O116E

Class Code: ACTIB

hypromelloses

Code: 3NXW29V3WO

Class Code: IACT

PANCRELIPASE PROTEASE

Quantity: 38000 [USP'U] in 1 1

Code: 3560D81V50

Class Code: ACTIB

dimethicone

Code: 92RU3N3Y1O

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

triethyl citrate

Code: 8Z96QXD6UM

Class Code: IACT

Active Moieties

PANCRELIPASE LIPASE

Code: 8MYC33932O

PANCRELIPASE AMYLASE

Code: YOJ58O116E

PANCRELIPASE PROTEASE

Code: 3560D81V50

Basic Information

Regulatory Information

Company Information

Active Ingredients

cetyl alcohol

hypromelloses

dimethicone

POLYETHYLENE GLYCOLS

triethyl citrate

Active Moieties

PANCRELIPASE LIPASE

PANCRELIPASE AMYLASE

PANCRELIPASE PROTEASE