Creon

Basic Information

Product Name

Creon

FDA Product Code

0032-1203

Regulatory Information

NDC Product Code

0032-1203

Application Number

BLA020725

Marketing Category

C73585

Effective Date

March 6, 2024

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

107

Active Ingredients

PANCRELIPASE AMYLASE

Quantity: 15000 [USP'U] in 1 1

Code: YOJ58O116E

Class Code: ACTIB

PANCRELIPASE PROTEASE

Quantity: 9500 [USP'U] in 1 1

Code: 3560D81V50

Class Code: ACTIB

PANCRELIPASE LIPASE

Quantity: 3000 [USP'U] in 1 1

Code: 8MYC33932O

Class Code: ACTIB

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)

Code: G4U024CQK6

Class Code: IACT

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

CARRAGEENAN

Code: 5C69YCD2YJ

Class Code: IACT

POTASSIUM CHLORIDE

Code: 660YQ98I10

Class Code: IACT

Active Moieties

PANCRELIPASE AMYLASE

Code: YOJ58O116E

PANCRELIPASE LIPASE

Code: 8MYC33932O

PANCRELIPASE PROTEASE

Code: 3560D81V50

Basic Information

Regulatory Information

Company Information

Active Ingredients

CETYL ALCOHOL

HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)

DIMETHICONE

POLYETHYLENE GLYCOL, UNSPECIFIED

TRIETHYL CITRATE

TITANIUM DIOXIDE

HYPROMELLOSE, UNSPECIFIED

CARRAGEENAN

POTASSIUM CHLORIDE

Active Moieties

PANCRELIPASE AMYLASE

PANCRELIPASE LIPASE

PANCRELIPASE PROTEASE