Creon
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 useInitial U.S. Approval: 2009
Approved
Approval ID
85e78b3c-66ac-4012-899b-1a55afe5110e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pancrelipase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6067
Application NumberNDA020725
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pancrelipase
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2012
FDA Product Classification
INGREDIENTS (8)
PANCRELIPASE LIPASEActive
Quantity: 12000 [USP'U] in 1 1
Code: 8MYC33932O
Classification: ACTIM
PANCRELIPASE PROTEASEActive
Quantity: 38000 [USP'U] in 1 1
Code: 3560D81V50
Classification: ACTIM
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
PANCRELIPASE AMYLASEActive
Quantity: 60000 [USP'U] in 1 1
Code: YOJ58O116E
Classification: ACTIM
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT