Quick answers
- What is Pancrelipase used for?
- The FDA-approved label (Creon, AbbVie Inc., February 28, 2024) says: “CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pancrelipase have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pancrelipase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pancrelipase been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started June 23, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Pancrelipase?
- 4 companies list prescription products of Pancrelipase in the FDA NDC Directory, including Aimmune Therapeutics, Inc., AbbVie Inc. and Vivus LLC.
What Pancrelipase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
— FDA label: Creon, AbbVie Inc., effective February 28, 2024. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| pancrelipase amylase 105000 USP units · pancrelipase lipase 25000 USP units · pancrelipase protease 79000 USP units capsule, delayed release | Brand: Zenpep | $10.15 per capsule |
| pancrelipase amylase 120000 USP units · pancrelipase lipase 24000 USP units · pancrelipase protease 76000 USP units capsule, delayed release pellets | Brand: Creon | $8.34 per capsule |
| pancrelipase amylase 14000 USP units · pancrelipase lipase 3000 USP units · pancrelipase protease 10000 USP units capsule, delayed release | Brand: Zenpep | $2.22 per capsule |
| pancrelipase amylase 15000 USP units · pancrelipase lipase 3000 USP units · pancrelipase protease 9500 USP units capsule, delayed release | Brand: Creon | $1.78 per capsule |
| pancrelipase amylase 168000 USP units · pancrelipase lipase 40000 USP units · pancrelipase protease 126000 USP units capsule, delayed release | Brand: Zenpep | $16.21 per capsule |
| pancrelipase amylase 180000 USP units · pancrelipase lipase 36000 USP units · pancrelipase protease 114000 USP units capsule, delayed release pellets | Brand: Creon | $12.67 per capsule |
| pancrelipase amylase 24000 USP units · pancrelipase lipase 5000 USP units · pancrelipase protease 17000 USP units capsule, delayed release | Brand: Zenpep | $2.12 per capsule |
| pancrelipase amylase 252600 USP units · pancrelipase lipase 60000 USP units · pancrelipase protease 189600 USP units capsule, delayed release | Brand: Zenpep | $24.32 per capsule |
| pancrelipase amylase 30000 USP units · pancrelipase lipase 6000 USP units · pancrelipase protease 19000 USP units capsule, delayed release pellets | Brand: Creon | $2.10 per capsule |
| pancrelipase amylase 30250 USP units · pancrelipase lipase 8000 USP units · pancrelipase protease 28750 USP units capsule, delayed release | Brand: Pertzye | $2.66 per capsule |
| pancrelipase amylase 39150 USP units · pancrelipase lipase 10440 USP units · pancrelipase protease 39150 USP units tablet | Brand: Viokace | $4.15 per tablet |
| pancrelipase amylase 42000 USP units · pancrelipase lipase 10000 USP units · pancrelipase protease 32000 USP units capsule, delayed release | Brand: Zenpep | $4.18 per capsule |
| pancrelipase amylase 60000 USP units · pancrelipase lipase 12000 USP units · pancrelipase protease 38000 USP units capsule, delayed release pellets | Brand: Creon | $4.21 per capsule |
| pancrelipase amylase 60500 USP units · pancrelipase lipase 16000 USP units · pancrelipase protease 57500 USP units capsule, delayed release | Brand: Pertzye | $5.33 per capsule |
| pancrelipase amylase 63000 USP units · pancrelipase lipase 15000 USP units · pancrelipase protease 47000 USP units capsule, delayed release | Brand: Zenpep | $6.04 per capsule |
| pancrelipase amylase 78300 USP units · pancrelipase lipase 20880 USP units · pancrelipase protease 78300 USP units tablet | Brand: Viokace | $8.21 per tablet |
| pancrelipase amylase 84000 USP units · pancrelipase lipase 20000 USP units · pancrelipase protease 63000 USP units capsule, delayed release | Brand: Zenpep | $8.20 per capsule |
| pancrelipase amylase 90750 USP units · pancrelipase lipase 24000 USP units · pancrelipase protease 86250 USP units capsule, delayed release | Brand: Pertzye | $8.05 per capsule |
NADAC list of November 4, 2026; these prices took effect between December 31, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aimmune Therapeutics, Inc.10 products
- AbbVie Inc.10 products
- Vivus LLC6 products
- Digestive Care, Inc.4 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA020725 CREON | Abbvie | April 30, 2009 | 19, latest February 28, 2024 2024: Labeling · 2022: Labeling · 2020: Labeling |
| BLA022175 PERTZYE | Digestive Care Inc | May 17, 2012 | 6, latest February 28, 2024 2024: Labeling · 2022: Labeling · 2020: Labeling |
| BLA022210 ZENPEP | Eurand Pharma Ltd | August 27, 2009 | 13, latest February 28, 2024 2024: Labeling · 2023: Labeling · 2022: Labeling |
| BLA022523 PANCREAZE | Vivus Inc | April 12, 2010 | 13, latest February 28, 2024 2024: Labeling · 2021: Labeling · 2020: Labeling |
| BLA022542 VIOKACE | Viokace | March 1, 2012 | 8, latest February 28, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2022: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 23, 2023 · Class III · Ongoing · D-0896-2023
Failed Stability Specifications
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10, — Vivus, Inc.
-
March 15, 2021 · Class II · Terminated · D-0402-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A. — Cardinal Health Inc.
-
September 15, 2014 · Class II · Terminated · D-1611-2014
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07. — AbbVie Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1247379, 1247381 … (+10) |
|---|---|
| SPL set ID of the quoted label | 073201aa-556d-4a70-918e-84e9616fd88d |
| FDA labels (SPL) | 5 |
| FDA applications | BLA020725, BLA022175, BLA022210, BLA022523, BLA022542 |
| Active ingredients (FDA) | PANCRELIPASE AMYLASE / PANCRELIPASE LIPASE / PANCRELIPASE PROTEASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Creon, AbbVie Inc., effective February 28, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →