FDA.reportPublic FDA data

Creon

Product NDC
17856-1212
11-digit product format
178561212
Labeler code
17856
Product ID
17856-1212_a5708817-22eb-45e9-a444-2b28f709201b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pancrelipase
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
NDA020725
Marketing category
NDA
Marketing start
2010-08-13
Marketing end
0000-00-00
Substance
PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active strength
12000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1212-12020-01-31C16284748780-19d75b9cf-d559-f424-e053-dadaa90a57ceThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1212-1Creon1 in 1 POUCHCAPSULE, DELAYED RELEASE PELLETS12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANCRELIPASE AMYLASEACTIVE INGREDIENTYOJ58O116ECREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
PANCRELIPASE LIPASEACTIVE INGREDIENT8MYC33932OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
PANCRELIPASE PROTEASEACTIVE INGREDIENT3560D81V50CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
PANCRELIPASE AMYLASEACTIVE MOIETYYOJ58O116ECREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
PANCRELIPASE LIPASEACTIVE MOIETY8MYC33932OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
PANCRELIPASE PROTEASEACTIVE MOIETY3560D81V50CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1212CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20120529_45b9a46b-3294-4604-8aea-60624d663020.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863841CREON 12,000 UNT / 60,000 UNT / 38,000 UNT Delayed Release Oral CapsulePSN45b9a46b-3294-4604-8aea-60624d6630202
855503lipase 12,000 UNT / amylase 60,000 UNT / protease 38,000 UNT Delayed Release Oral CapsulePSN45b9a46b-3294-4604-8aea-60624d6630202
863841amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral Capsule [Creon]SBD45b9a46b-3294-4604-8aea-60624d6630202
855503amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral CapsuleSCD45b9a46b-3294-4604-8aea-60624d6630202
855503amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT Delayed Release Oral CapsuleSY45b9a46b-3294-4604-8aea-60624d6630202
855503amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT Delayed Release Oral CapsuleSY45b9a46b-3294-4604-8aea-60624d6630202
863841Creon (amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT) Delayed Release Oral CapsuleSY45b9a46b-3294-4604-8aea-60624d6630202
863841Creon 12 (amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT) Delayed Release Oral CapsuleSY45b9a46b-3294-4604-8aea-60624d6630202
863841Creon 12,000 (lipase) Delayed Release Oral CapsuleSY45b9a46b-3294-4604-8aea-60624d6630202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-1212-1178561212011 in 1 POUCHHistorical