FDA.reportPublic FDA data

Creon

Product NDC
0032-3016
11-digit product format
000323016
Labeler code
0032
Product ID
0032-3016_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
2013-03-14
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
180000; 36000; 114000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0032-30160032-3016-50DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CreonPANCRELIPASEAbbVie Inc.073201aa-556d-4a70-918e-84e9616fd88d2024-02-28Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Fibrosing C olonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) I rritation of the O ral M ucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 2.3 , 5.2 ) Hyperuricemia: Reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia. ( 5.3 ) Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. ( 5.4 ) Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment. ( 5.5 ) 5.1 Fibrosing Colonopathy Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown. If there is history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation . Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Patients receiving dosages highe...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions ( 5.1 )] Irritation of the Oral Mucosa [see Warnings and Precautions ( 5.2 )] Hyperuricemia [see Warnings and Precautions ( 5.3 )] Risk of Viral Transmission [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients : 7 years and older (≥4%): vomiting, dizziness, cough. 4 months to 6 years (6%): vomiting, irritability, decreased appetite. C hronic pancreatitis or pancreatectomy patient s: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to CREON in 92 patients: 67 patients aged 4 months to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis (Studies 1, 2, and 3) and 25 adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (Study 4) [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 , 14.2 )] . Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis in Adult and Pediatric Patients Adult and Pediatric Patients 7 Years of Age and Older The most common adverse reactions, reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Studies 1 and 2, are shown in Table 1. Table 1: Adverse Reactions* in Clinical Trials of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Studies 1 and 2) Adverse Reaction CREON N = 49 n (%) Placebo N = 47 n (%) Vomiting 3 (6%) 1 (2%) Dizziness 2 (4%) 1 (2%) Cough 2 (4%) 0 (0%) * Reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than...

adverse reactions table

Table 1: Adverse Reactions* in Clinical Trials of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Studies 1 and 2) Adverse ReactionCREON N = 49 n (%)Placebo N = 47 n (%) Vomiting 3 (6%) 1 (2%) Dizziness 2 (4%) 1 (2%) Cough 2 (4%) 0 (0%)

Additional Listing Data#

Finished product
Yes
Brand name base
Creon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE LIPASE180000 [USP'U]/1
PANCRELIPASE AMYLASE36000 [USP'U]/1
PANCRELIPASE PROTEASE114000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MYC33932O, YOJ58O116E, 3560D81V50
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
0032-3016-122025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-122025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-132025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-132025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-282025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-282025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-502025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-502025-08-01C16284748780-13b156c62-2ea8-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
0032-3016-122025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-122025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-132025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-132025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-282025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-282025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-502025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-502025-07-29C16284748780-13b156c62-2ea8-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
0032-3016-12Creon1 in 1 CARTONCAPSULE, DELAYED RELEASE PELLETS1108
0032-3016-12Creon12 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS12108
0032-3016-13Creon100 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS100108
0032-3016-28Creon250 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS250108
0032-3016-50Creon50 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS50108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0032-3016-13EA - Each0032-301601e7a2aa-cb4f-49d7-a351-0b98d33f392f12013-05-02
0032-3016-28EA - Each0032-3016f661fea4-bd07-4348-85f5-527cf690d9ac12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANCRELIPASE AMYLASEACTIVE INGREDIENTYOJ58O116ECREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
PANCRELIPASE LIPASEACTIVE INGREDIENT8MYC33932OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
PANCRELIPASE PROTEASEACTIVE INGREDIENT3560D81V50CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
PANCRELIPASE AMYLASEACTIVE MOIETYYOJ58O116ECREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
PANCRELIPASE LIPASEACTIVE MOIETY8MYC33932OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
PANCRELIPASE PROTEASEACTIVE MOIETY3560D81V50CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
GELATININACTIVE INGREDIENT2G86QN327LCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMCREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE [ABBVIE INC.]57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0032-3016CREON (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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020725Creonpancrelipase351(a)Rx2026-06-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0032-3016-12000323016121 BOTTLE in 1 CARTON (0032-3016-12) / 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE1 bottle2013-03-140000-00-00YesNoCurrent
0032-3016-1300032301613100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-13) 2013-03-140000-00-00NoNoCurrent
0032-3016-2800032301628250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-28) 2013-03-140000-00-00NoNoCurrent
0032-3016-500003230165050 in 1 BOTTLEHistorical