FDA.reportPublic FDA data

Creon

Product NDC
0032-1206
11-digit product format
000321206
Labeler code
0032
Product ID
0032-1206_94463229-9296-4640-854f-41d76386d312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pancrelipase
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
AbbVie Inc.
Application
BLA020725
Marketing category
BLA
Marketing start
2009-04-30
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Creon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE AMYLASE30000 [USP'U]/1
PANCRELIPASE LIPASE6000 [USP'U]/1
PANCRELIPASE PROTEASE19000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3560D81V50, YOJ58O116E, 8MYC33932O
Rxcui855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1373325, 1373327

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0032-1206-012025-08-01C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-072025-08-01C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-562025-08-01C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-012025-07-29C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-072025-07-29C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-562025-07-29C16284748780-13b156c62-2ea8-fb37-e063-e6dba90a4e07These 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
0032-1206-01Creon100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100108
0032-1206-01Creon1 in 1 CARTONCAPSULE, DELAYED RELEASE PELLETS1108
0032-1206-07Creon250 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS250108
0032-1206-56Creon100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100108
0032-1206-56Creon1 in 1 CARTONCAPSULE, DELAYED RELEASE PELLETS1108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0032-1206CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ABBVIE INC.]107Current NDC, Legacy NDC, 5 package rows20240308_073201aa-556d-4a70-918e-84e9616fd88d.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 CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
863829CREON 24,000 UNT / 120,000 UNT / 76,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
1113046CREON 3000 UNT / 15,000 UNT / 9500 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
1373327CREON 36,000 UNT / 180,000 UNT / 114,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
863836CREON 6000 UNT / 30,000 UNT / 19,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
855503lipase 12,000 UNT / amylase 60,000 UNT / protease 38,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
855495lipase 24,000 UNT / amylase 120,000 UNT / protease 76,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
1113042lipase 3000 UNT / amylase 15,000 UNT / protease 9500 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
1373325lipase 36,000 UNT / amylase 180,000 UNT / protease 114,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
855499lipase 6000 UNT / amylase 30,000 UNT / protease 19,000 UNT Delayed Release Oral CapsulePSN073201aa-556d-4a70-918e-84e9616fd88d108
863829amylase 120000 UNT / lipase 24000 UNT / protease 76000 UNT Delayed Release Oral Capsule [Creon]SBD073201aa-556d-4a70-918e-84e9616fd88d108
1113046amylase 15000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral Capsule [Creon]SBD073201aa-556d-4a70-918e-84e9616fd88d108
1373327amylase 180000 UNT / lipase 36000 UNT / protease 114000 UNT Delayed Release Oral Capsule [Creon]SBD073201aa-556d-4a70-918e-84e9616fd88d108
863836amylase 30000 UNT / lipase 6000 UNT / protease 19000 UNT Delayed Release Oral Capsule [Creon]SBD073201aa-556d-4a70-918e-84e9616fd88d108
863841amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral Capsule [Creon]SBD073201aa-556d-4a70-918e-84e9616fd88d108
855495amylase 120000 UNT / lipase 24000 UNT / protease 76000 UNT Delayed Release Oral CapsuleSCD073201aa-556d-4a70-918e-84e9616fd88d108
1113042amylase 15000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral CapsuleSCD073201aa-556d-4a70-918e-84e9616fd88d108
1373325amylase 180000 UNT / lipase 36000 UNT / protease 114000 UNT Delayed Release Oral CapsuleSCD073201aa-556d-4a70-918e-84e9616fd88d108
855499amylase 30000 UNT / lipase 6000 UNT / protease 19000 UNT Delayed Release Oral CapsuleSCD073201aa-556d-4a70-918e-84e9616fd88d108
855503amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral CapsuleSCD073201aa-556d-4a70-918e-84e9616fd88d108
855495amylase 120,000 UNT / lipase 24,000 UNT / protease 76,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113042amylase 15,000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1373325amylase 180,000 UNT / lipase 36,000 UNT / protease 114,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
855499amylase 30,000 UNT / lipase 6000 UNT / protease 19,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
855503amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
855495amylases 120,000 UNT / endopeptidases 76,000 UNT / lipase 24,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113042amylases 15,000 UNT / endopeptidases 9500 UNT / lipase 3000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1373325amylases 180,000 UNT / endopeptidases 114,000 UNT / lipase 36,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
855499amylases 30,000 UNT / endopeptidases 19,000 UNT / lipase 6000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
855503amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1373327Creon (amylase 180,000 UNT / protease 114,000 UNT / lipase 36,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863829Creon (amylases 120,000 UNT / endopeptidases 76,000 UNT / lipase 24,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113046Creon (amylases 15,000 UNT / endopeptidases 9500 UNT / lipase 3000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1373327Creon (amylases 180,000 UNT / endopeptidases 114,000 UNT / lipase 36,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863836Creon (amylases 30,000 UNT / endopeptidases 19,000 UNT / lipase 6000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863841Creon (amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863841Creon 12 (amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863841Creon 12,000 (lipase) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863829Creon 24 (amylase 120,000 UNT / lipase 24,000 UNT / protease 76,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863829Creon 24 Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863829Creon 24,000 (lipase) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113046Creon 3 (amylase 15,000 UNT / lipase 3000 UNT / protease 9500 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113046Creon 3 Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
1113046Creon 3000 (lipase) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863836Creon 6 (amylase 30,000 UNT / lipase 6000 UNT / protease 19,000 UNT) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863836Creon 6,000 (lipase) Delayed Release Oral CapsuleSY073201aa-556d-4a70-918e-84e9616fd88d108
863836CREON 6000 UNT / 30,000 UNT / 19,000 UNT Delayed Release Oral CapsulePSN0ebe90a9-b027-419a-9920-c254bc3c80e82
855499lipase 6000 UNT / amylase 30,000 UNT / protease 19,000 UNT Delayed Release Oral CapsulePSN0ebe90a9-b027-419a-9920-c254bc3c80e82
863836amylase 30000 UNT / lipase 6000 UNT / protease 19000 UNT Delayed Release Oral Capsule [Creon]SBD0ebe90a9-b027-419a-9920-c254bc3c80e82
855499amylase 30000 UNT / lipase 6000 UNT / protease 19000 UNT Delayed Release Oral CapsuleSCD0ebe90a9-b027-419a-9920-c254bc3c80e82
855499amylase 30,000 UNT / lipase 6000 UNT / protease 19,000 UNT Delayed Release Oral CapsuleSY0ebe90a9-b027-419a-9920-c254bc3c80e82
855499amylases 30,000 UNT / endopeptidases 19,000 UNT / lipase 6000 UNT Delayed Release Oral CapsuleSY0ebe90a9-b027-419a-9920-c254bc3c80e82
863836Creon (amylases 30,000 UNT / endopeptidases 19,000 UNT / lipase 6000 UNT) Delayed Release Oral CapsuleSY0ebe90a9-b027-419a-9920-c254bc3c80e82
863836Creon 6 (amylase 30,000 UNT / lipase 6000 UNT / protease 19,000 UNT) Delayed Release Oral CapsuleSY0ebe90a9-b027-419a-9920-c254bc3c80e82
863836Creon 6,000 (lipase) Delayed Release Oral CapsuleSY0ebe90a9-b027-419a-9920-c254bc3c80e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0032-1206-01000321206011 BOTTLE in 1 CARTON (0032-1206-01) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE1 bottle2009-04-300000-00-00NoNoCurrent
0032-1206-0700032120607250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1206-07) 2009-04-300000-00-00NoNoCurrent
0032-1206-56000321206561 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE1 bottle2009-04-300000-00-00YesNoCurrent