MedPath
FDA Product

Creon

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Creon

0032-1206

Regulatory Information

0032-1206

BLA020725

C73585

March 6, 2024

USA

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

HUMAN PRESCRIPTION DRUG LABEL

107

Company Information

AbbVie Inc.

078458370

Active Ingredients

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

PANCRELIPASE AMYLASE

Quantity: 30000 [USP'U] in 1 1

Code: YOJ58O116E

Class Code: ACTIB

CARRAGEENAN

Code: 5C69YCD2YJ

Class Code: IACT

PANCRELIPASE LIPASE

Quantity: 6000 [USP'U] in 1 1

Code: 8MYC33932O

Class Code: ACTIB

PANCRELIPASE PROTEASE

Quantity: 19000 [USP'U] in 1 1

Code: 3560D81V50

Class Code: ACTIB

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)

Code: G4U024CQK6

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POTASSIUM CHLORIDE

Code: 660YQ98I10

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

PANCRELIPASE PROTEASE

Code: 3560D81V50

PANCRELIPASE LIPASE

Code: 8MYC33932O

PANCRELIPASE AMYLASE

Code: YOJ58O116E

© Copyright 2025. All Rights Reserved by MedPath