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Creon

Pancrelipase · Capsule, Delayed Release

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Creon
Generic name
Pancrelipase
Dosage form
Capsule, Delayed Release
Route
Oral
Marketing category
BLA · BLA
Labeler
AbbVie Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
2
Packages
4
Data completeness
53% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Pancrelipase Amylase 15000 [USP'U]/1 855495 View
Pancrelipase Lipase 3000 [USP'U]/1 855495 View
Pancrelipase Protease 9500 [USP'U]/1 855495 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Delayed Release
Route of administration
Oral
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020725
Application type
BLA · Biologics License Application
Approval date
April 30, 2009
Sponsor
ABBVIE
Products on application
5
Submissions recorded
20
Products approved under application 020725.
Product Trade name Form Strength Ingredient Status TE Flags
020725-001 CREON CAPSULE, DELAYED RELEASE PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) Prescription —
020725-002 CREON CAPSULE, DELAYED RELEASE PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) Prescription —
020725-003 CREON CAPSULE, DELAYED RELEASE PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) Prescription —
020725-004 CREON CAPSULE, DELAYED RELEASE PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) Prescription —
020725-005 CREON CAPSULE, DELAYED RELEASE PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 020725.
Type No. Action Status Date Review
Supplement 31 Labeling Approved February 28, 2024 Standard
Supplement 28 Labeling Approved June 2, 2022 Standard
Supplement 26 Labeling Approved March 20, 2020 Standard
Supplement 25 Labeling Approved May 9, 2019 Standard
Supplement 23 Manufacturing (CMC) Approved June 16, 2016 Priority
Supplement 22 Manufacturing (CMC) Approved April 10, 2015 Priority
Supplement 21 Manufacturing (CMC) Approved January 5, 2015 Priority
Supplement 18 Manufacturing (CMC) Approved November 21, 2014 Priority
Supplement 20 Manufacturing (CMC) Approved November 19, 2014 Priority
Supplement 9 Manufacturing (CMC) Approved March 17, 2014 Priority
Supplement 16 Manufacturing (CMC) Approved March 14, 2013 Priority
Supplement 17 Manufacturing (CMC) Approved February 28, 2013 Priority
Supplement 15 Manufacturing (CMC) Approved November 20, 2012 Priority
Supplement 8 Efficacy Approved July 12, 2011 Standard
Supplement 11 Manufacturing (CMC) Approved June 10, 2011 Priority
Supplement 14 REMS Approved May 9, 2011 N/A
Supplement 7 REMS Approved August 12, 2010 N/A
Supplement 6 Efficacy Approved July 29, 2010 Standard
Supplement 3 Efficacy Approved April 30, 2010 Standard
Original application 1 Type 7 - Drug Already Marketed without Approved NDA Approved April 30, 2009 Priority

Review documents

Adverse event reports

Source: openFDA FAERS
6,985
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PANCRELIPASE LIPASE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. Terminated
Class II October 8, 2014 AbbVie Inc Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0032-0045-30 0032-0045 AbbVie Inc. 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0032-0045-30) October 12, 2023
0032-0045-70 0032-0045 AbbVie Inc. 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0032-0045-70) October 12, 2023
0032-1203-64 0032-1203 AbbVie Inc. 1 BOTTLE in 1 CARTON (0032-1203-64) / 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE April 30, 2009
0032-1203-70 0032-1203 AbbVie Inc. 1 BOTTLE in 1 CARTON (0032-1203-70) / 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE April 30, 2009
0032-0045 0032-0045 AbbVie Inc. — October 12, 2023
0032-1203 0032-1203 AbbVie Inc. — April 30, 2009

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Enforcement FDA Recall records
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.