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Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 Capsule, Delayed Release Pellets, 100-count

by AbbVie Inc. · 1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

NDC 00032-1206-56

🏷️ FDA NDC (as labeled) 0032-1206-56 billing pads the labeler segment with a zero

This package

Contains100-count Pack sizes3 compare ↓

Also priced by: Part D plans $2.11/unit — full pricing hub ↓

Also comes in: 100 capsules 00032-1206-01 250 capsules 00032-1206-07

Rx only Brand On market Non-controlled

🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0032-1206-56

Product NDC 0032-1206

11-digit billing NDC 00032120656

RxCUI 855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046,

UNII 8MYC33932O, YOJ58O116E, 3560D81V50

UPC 0300322637701, 0300320045706, 0300320047700, 0300320046703 +4 more

Application # BLA020725

SPL Set ID 073201aa-556d-4a70-918e-84e9616fd88d

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2009-04-30

Route ORAL

Dosage form CAPSULE, DELAYED RELEASE PELLETS

Substance PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE

GCN Seq No 065328

GCN 26176

HICL code 008060

Ingredient (HICL) Lipase/Protease/Amylase (Pork)

HIC1 code D

Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System

HIC2 code D8

Therapeutic class — intermediate (HIC2) Effect Or From Pancreas (Except Insulin)

HIC3 code D8A

Therapeutic class — specific (HIC3) Pancreatic Enzymes

AHFS code 56:16.00.00

AHFS class Digestants

FDB label name CREON DR 6,000 UNIT CAPSULE

FDB brand name Creon

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 0032-1206-56 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00032-1206-56. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAbbVie Inc.

FDA applicationBLA020725 (BLA)

Labeler code00032

First marketedApr 2009

Product typeHuman Prescription Drug

Portfolio129 products on file

🔎 All NDCs from AbbVie Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CREON DR 6,000 UNIT CAPSULE Ingredient Lipase/Protease/Amylase (Pork)

📗 Our plain-language guide HelloPharmacist

The enzymes in pancrelipase only work when there's food for them to digest — so timing really does matter. Even a small snack needs about half your usual meal dose. Skipping doses...
Why do I have to take this with every meal? Can I skip it if I'm not very hungry?
Yes, but carefully. You can sprinkle the contents onto a small amount of soft, acidic food like applesauce — just make sure to swallow it right away without chewing. What you absol...
Can I open the capsule if I have trouble swallowing it?

📖 Read our full Pancrelipase guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Pancrelipase (prescription drug) — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Pancrelipase (prescription drug) (19 interactions) — ranked by severity →

Nutrient depletion considerations

Pancrelipase (prescription drug) may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

FOLIC ACID Moderate Depletion IRON Moderate Depletion

🧪 Full Pancrelipase (prescription drug) nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white / blue / orange / brown

ShapeCapsule

ImprintCREON;1236

Size25 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII G4U024CQK6
Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$2.11	$210.94 / 100 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Creon 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U] 00032-0046-30	AbbVie	100 capsules	—	—	FDA listed	—
Creon 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]this 00032-1206-56	AbbVie	100 capsules	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

1996

First FDA approval

Dec 1996

📍

2026

Currently FDA-listed

30 years listed

🧬

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Cotazympancrelipase Creonpancrelipase Pancreazepancrelipase Pertzyepancrelipase Viokacepancrelipase Zenpeppancrelipase

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

100 capsules00032-1206-01 25 Rx · $7,797

250 capsules00032-1206-07 No Medicaid data

100 capsules this page00032-1206-56 No Medicaid data

Drug total (last 4 qtrs): 25 Rx · 3,654 units · $7,797 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Creon — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Creon. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$418.5M

Claims incl. refills

174.1K

Beneficiaries

102.5K

Spend / beneficiary

$4,081.27

Spend / claim

$2,403.91

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Creon (this brand).

Top reported reactions

Diarrhoea3,668

Death1,967

Nausea1,843

Weight Decreased1,777

Fatigue1,609

Abdominal Pain1,539

Vomiting1,438

Age at onset

Neonate22

Infant26

Child203

Adolescent223

Adult2,624

Elderly2,597

Reporter sex

Male · 44%

Female · 56%

Unknown · 0%

Serious outcomes

Hospitalization14,294

Death3,795

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00032-1206-01	1 BOTTLE in 1 CARTON (0032-1206-01) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE	$2.10 / ea	$210.49	2009-04-30	Active
00032-1206-07	250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1206-07)	$1.99 / ea	$496.58	2009-04-30	Active
00032-1206-56 You're viewing this	1 BOTTLE in 1 CARTON (0032-1206-56) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE	—	—	2009-04-30	Active

Pack size FAQ

What quantity is in NDC 00032-1206-56?

NDC 00032-1206-56 is a 100-count package — 1 bottle in 1 carton / 100 capsule, delayed release pellets in 1 bottle.

What is the difference between NDC 00032-1206-56 and NDC 00032-1206-01?

Both are Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 Capsule, Delayed Release Pellets — the drug itself is identical. NDC 00032-1206-56 is the 100-count package, while NDC 00032-1206-01 is the 100 capsules package.

What NDC number is used to bill for this package of Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 Capsule, Delayed Release Pellets?

Bill NDC 00032-1206-56 — the 11-digit billing format is 00032120656. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0032-1206-56, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00032-1206-56, written without dashes as 00032120656. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00032-1206-56, the first segment (00032) is the labeler code FDA assigned to AbbVie Inc.; the middle segment (1206) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (56) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AbbVie Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 100 capsules (00032-1206-01), 250 capsules (00032-1206-07). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

AbbVie Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 35 words ▾

1 INDICATIONS AND USAGE 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.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) CREON is a mixture of enzymes including lipases, proteases, and amylases, and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

Do not exceed 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. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.

Do not substitute other pancreatic enzyme products for CREON. When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adult and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years and older.

500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years. Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day.

Higher dosages may be administered if documented effective by fecal fat measures or improvement of malabsorption. Pediatric Patients Birth to 12 Months : The recommended dosage is 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Preparation and Administration Instructions ( 2.3 ) Swallow capsules whole.

For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt). Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids to ensure complete swallowing of CREON.

( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months.

2.1Important Dosing Information CREON is a mixture of enzymes including lipases, proteases, and amylases. CREON dosing is based on lipase units. Use either an actual body weight or fat ingestion-based dosing scheme.

Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days. Do not exceed 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 [see Warnings and Precautions ( 5.1 )] .

The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed CREON dose for a meal. Do not substitute other pancreatic enzyme products for CREON.

When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

2.2Recommended Dosage Adult and Pediatric Patients Greater than 12 Months of Age The recommended oral initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years of age and older. 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age.

If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500 lipase…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Delayed-release capsules are available in the following strengths: 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase in a two-piece capsule with a white opaque cap imprinted with “CREON 1203” and a white opaque body. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase in a two-piece capsule with an orange opaque cap imprinted with “CREON 1206” and a blue opaque body. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase in a two-piece capsule with a brown opaque cap imprinted with “CREON 1212” and a colorless transparent body.

24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase in a two-piece capsule with an orange opaque cap imprinted with “CREON 1224” and a colorless transparent body. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase in a two-piece capsule with a blue opaque cap imprinted with “CREON 1236” and a colorless transparent body. Delayed-Release Capsules ( 3 ): 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

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 )

5.1Fibrosing 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 higher than 6,000 lipase units/kg/meal should be frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration ( 2.1 )] .

5.2Irritation of the Oral Mucosa Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: Swallow capsules whole. For patients who cannot swallow the capsules whole, the capsules can be opened, and the contents sprinkled in a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt).

Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of CREON to ensure complete swallowing. Visually inspect the mouth of pediatric patients less than 12 months of age and of patients who are unable to swallow intact capsules to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration ( 2.3 )] .

5.3Hyperuricemia Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage ( 10 )]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperur…

🤒 Adverse Reactions ~3 min read ▾

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.

6.1Clinical 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 placebo-treated patients.

In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with CREON. Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving CREON and a macrolide antibiotic. Pediatric Patients 4 Months to 6 Years of Age Adverse reactions reported in 18 CREON-treated pediatric patients aged 4 months to 6 years in Study 3 were vomiting, irritability, and decreased appetite, each occurring in 6% of patients [see Use in Specific Populations ( 8.4 )] .

Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy in Adults Adverse reactions reported in at least 1 adult CREON-treated patient (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Study 4 is shown in Table 2. Table 2: Adverse Reactions* in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy (Study 4) Adverse Reaction CREON N = 25 n (%) Placebo N = 29 n (%) Hyperglycemia 2 (8%) 2 (7%) Hypoglycemia 1 (4%) 1 (3%) Abdominal Pain 1 (4%) 1 (3%) Abnormal Feces 1 (4%) 0 (0%) Flatulence 1 (4%) 0 (0%) Frequent Bowel Movements 1 (4%) 0 (0%) Nasopharyngitis 1 (4%) 0 (0%) * Reported in at least 1 CREON-treated patient (greater than or equal to 4%) and at a higher rate than placebo-treated patients.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of CREON or other pancreatic enzyme products. Because these reactions are repor…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.

The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Pancrelipase is minimally absorbed systemically following oral administration; therefore, maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CREON and any potential adverse effects on the breastfed infant from CREON or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of CREON for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of CREON for this indication is supported by two adequate and well-controlled trials in adult and pediatric patients 12 years and older (Study 1) and in pediatric patients 7 to 11 years of age (Study 2) along with supportive data from an open-label, single-arm, study in 18 pediatric patients 4 months to six years of age (Study 3). All three study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis.

The safety in pediatric patients 7 years of age and older in Studies 1 and 2 were similar to that observed adult patients [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . In Study 3, patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by CREON (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). The mean daily fat intake was 48 grams during treatment with usual pancreatic enzyme replacement therapy and 47 grams during treatment with CREON.

Adverse reactions that occurred in patients during treatment with CREON in Study 3 were vomiting, irritability, and decreased appetite [see Adverse Reactions ( 6.1 )] . Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to stricture formation.

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 pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity.

🤰 Pregnancy 118 words ▾

🧒 Pediatric Use ~2 min read ▾

Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 ) ] .

🧓 Geriatric Use 49 words ▾

8.5Geriatric Use Clinical studies of CREON did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

🆘 Overdosage 47 words ▾

10 OVERDOSAGE Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions ( 5.1 )] . High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions ( 5.3 )] .

🧬 Clinical Pharmacology 162 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

12.2Pharmacodynamics For patients consuming a high fat diet in the clinical trials, the coefficient of fat absorption (CFA) was higher in patients who received CREON compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies ( 14.1 , 14.2 )] .

12.3Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from CREON are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of CREON are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.

🧬 Mechanism of Action 64 words ▾

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING CREON (pancrelipase) delayed-release capsules, containing tan-colored enteric-coated pancrelipase spheres, are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase Two-piece hypromellose capsule, white opaque cap imprinted “CREON 1203”, white opaque body Bottles of 70 0032-0045-70 0032-1203-70 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-0046-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-1206-01 Bottles of 250 0032-1206-07 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase Two-piece hypromellose capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-0047-70 Two-piece gelatin capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-1212-01 Bottles of 250 0032-1212-07 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-2636-01 Bottles of 240 0032-2636-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-1224-01 Bottles of 250 0032-1224-07 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase Two-piece hypromellose capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-2637-01 Bottles of 240 0032-2637-70 Two-piece gelatin capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-3016-13 Bottles of 250 0032-3016-28 Storage and Handling Store CREON at room temperature, 15°C to 25°C (59°F to 77°F), and protect from moisture.

Temperature excursions are permitted between 25°C to 40°C (77°F to 104°F) for up to 30 days. Discard CREON if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.

Keep the desiccant in the bottle if present . Store and dispense CREON in the original container.

📋 Description ~1 min read ▾

11 DESCRIPTION Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows: 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride.

6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide.

12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide.

36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2.

CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide ). Fibrosing Colonopathy Advise the patient or caregiver that fibrosing colonopathy has been reported with high dosages of pancreatic enzyme products, usually with use over a prolonged period of time and in pediatric patients with cystic fibrosis. Colonic stricture has been reported in pediatric patients less than 12 years of age.

Advise patients and caregivers that if signs and symptoms of colon stricture formation occur (e.g., stomach area (abdominal) pain, bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to immediately contact their healthcare provider [see Warnings and Precautions ( 5.1 ) ] . Hyperuricemia Advise the patient or caregiver that hyperuricemia may occur in patients with gout or renal impairment and to contact the healthcare provider if they experience pain, stiffness, redness or swelling of their joints [see Warnings and Precautions ( 5.3 )].

Hypersensitivity Reactions Inform the patient or caregiver that severe hypersensitivity reactions, including anaphylaxis, asthma, hives, and pruritus, have been reported with use of pancreatic enzyme products. Seek medical attention if signs or symptoms of a hypersensitivity reaction develop [see Warnings and Precautions ( 5.5 )] . Dos age Advise the patient or caregiver to take or administer CREON as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see Dosage and Administration ( 2.2 )] .

Administration Instruct the patient or caregiver as follows: Take CREON during meals and snacks. Swallow capsules whole. For adult and pediatric patients unable to swallow intact capsules, the capsule contents may be sprinkled on a small amount of soft acidic food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt).

For pediatric patients birth to 12 months of age, CREON capsules can also be opened, and the capsule contents sprinkled directly into the infant’s mouth. Consume sufficient liquids (juice, water, breast milk, or formula) and visually inspect an infant’s mouth to ensure complete swallowing of CREON capsules or capsule contents [see Warnings and Precautions ( 5.2 )] . Do not crush or chew CREON capsules or capsule contents.

Do not mix the CREON capsule contents directly into a bottle of breast milk or formula. Storage Instruct the patient or caregiver as follows: Keep CREON in a dry place and protect from heat. After opening, keep the bottle tightly closed between uses to protect from moisture.

North Chicago, IL 60064, U.S.A. US License Number 1889 20082735 February, 2024

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE CREON® (krē ′ŏn) (pancrelipase) delayed-release capsules, for oral use What is the most important information I should know about CREON? CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery.

The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Call your healthcare provider right away if you have any unusual or severe: stomach area (abdominal) pain bloating trouble passing stool (having bowel movements) nausea, vomiting, or diarrhea Take CREON exactly as prescribed. Do not take more or less CREON than directed by your healthcare provider.

What is CREON? CREON is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. CREON contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

CREON is safe and effective in adults and children. Before you tak e CREON, tell your healthcare provider about all your medical conditions, including if you: are allergic to pork (pig) products. have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy). have gout, kidney disease, or high blood uric acid (hyperuricemia). have trouble swallowing capsules. have any other medical condition. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.

It is not known if CREON passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take CREON. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take CREON?

Take CREON exactly as your healthcare provider tells you. Contact your healthcare provider if you continue to have signs and symptoms of malabsorption (not absorbing nutrients from food) such as abdominal pain, abdominal distention, bloating, fatty stools, or weight loss. Your dose may need to be changed.

You should not switch CREON with any other pancreatic enzyme product without first talking to your healthcare provider. Do not take more capsules in a day than the number your healthcare provider tells you to take (total daily dose). Always take CREON with a meal or snack and enough liquid (water, juice, breast milk, or formula) to swallow CREON completely.

If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose. Your healthcare provider may change your dose based on the amount of fatty foods you eat or based on your weight. CREON capsules should be swallowed whole.

Do not crush or chew CREON capsules or its contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing or holding the CREON capsules in your mouth may cause irritation in your mouth or change the way CREON works in your body. Giving CREON to A dults and C hildren O lder than 12 M onths of Age Swallow CREON capsules whole without crushing or chewing them.

If you have trouble swallowing capsules: Carefully open the capsules and sprinkle the entire contents on small amounts of acidic soft food such as applesauce, bananas, or plain Greek yogurt. Ask your healthcare provider about other foods you can use. Mix the capsule contents with the soft food.

Do not crush the contents. Swallow the mixture right away. Do not save it for later use.

Drink enough water or juice right away to make sure the medicine is swallowed completely. If you forget to take CREON, call your healthcare provider or wait until your next meal and take your usual number of capsules. Take your next dose at your usual t…

Glossary — plain-language definitions of medical terms used in this label:

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastritis: Swelling or irritation of the lining of the stomach.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 00032-1203-64 · AbbVie 00032-1212-01 · AbbVie →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 Capsule, Delayed Release Pellets, 100-count

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