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Pertzye pancrelipase 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]/1 Capsule, Delayed Release, 200-count — NDC 59767-0024-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pertzye pancrelipase 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]/1 Capsule, Delayed Release, 200-count — NDC 59767-024-02 (Billing 59767-0024-02)

by Digestive Care, Inc. · 200 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 200 capsules of Pertzye pancrelipase 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]/1 Capsule, Delayed Release from Digestive Care, Inc., marketed since Jul 2017 and currently FDA-listed; retail pharmacies pay about $8.04 per capsule (NADAC).

NDC 59767-0024-02
🏷️ FDA NDC (as labeled) 59767-024-02 billing pads the product segment with a zero
This package
Contains200-count Cost per ea$8.04 NADAC Per package$1,607.76 / 200 capsules Pack sizes4 compare ↓
Also priced by: Medicaid pays $7.88/unit · Part D plans $1.69/unit — full pricing hub ↓
Product page 59767-0024-01 Also comes in: 20 capsules 59767-024-00 80 capsules 59767-024-01 80 capsules 59767-024-99
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

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

NDC database record

One package, one record: these facts belong to NDC 59767-024-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59767 labeler · 024 product · 02 package
Package marketed since
Jul 13, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
200 EA per package
Barcode (UPC-A, from the NDC)
3 5976702402 7
Medicaid fills, this package
207 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59767-024-02
Product NDC 59767-024
11-digit billing NDC 59767002402
NCPDP billing unit EA — each (per item)
RxCUI 1294122, 1294128, 1294481, 1294483, 1543004, 1543006, 1929116, 1929118
UNII YOJ58O116E, 3560D81V50, 8MYC33932O
Application # BLA022175
SPL Set ID 481eec00-9abf-11dd-b71c-0002a5d5c51b
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-13
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 51200024006762
GPI class Pertzye
GCN Seq No 077665
GCN 43756
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 PERTZYE DR 24,000 UNIT CAPSULE
FDB brand name Pertzye
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077665
  • GCN: 43756
  • GPI-14 (Medi-Span): 51200024006762
  • HICL (First Databank): 008060
  • AHFS class code: 56:16.00.00
  • RxCUI (RxNorm): 1294122
Why two NDCs? The FDA registers this code as 59767-024-02 — a 5-3-2 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 product segment → 59767-0024-02. 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.

Clinical

Label name PERTZYE DR 24,000 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 →
2
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.

🧪 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.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $8.039 $1,607.76 / 200 capsules
Medicaid paysCMS SDUD · 12 mo $7.88 $1,575.38 / 200 capsules
Medicare drug plans payPart D · Q2 2026 $1.69 $338.66 / 200 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 May 2026 Jul 2026 Sep 2026 $8.039 $7.988
▲ Up 1% over the last 6 months.
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59767-0024-01 59767-024-01 Main listing 80 CAPSULE, DELAYED RELEASE in 1 BOTTLE $8.04 / ea $643.11 2017-07-13 — Active
59767-0024-02 You're viewing this 200 CAPSULE, DELAYED RELEASE in 1 BOTTLE $8.04 / ea $1,607.77 2017-07-13 — Active
59767-0024-00 59767-024-00 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE Sample — — 2017-07-13 — Active
59767-0024-99 59767-024-99 80 CAPSULE, DELAYED RELEASE in 1 BOTTLE Sample — — 2017-07-13 — Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($8.04 NADAC).

This pack accounts for about 14% of this product's recent Medicaid fills; most go to the 80 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 200-count package — 200 capsule, delayed release in 1 bottle.
How does this package differ from NDC 59767-0024-00?
Both are Pertzye pancrelipase 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]/1 Capsule, Delayed Release — the drug itself is identical. This page's package is the 200-count one, while NDC 59767-0024-00 is the 20 capsules package.
What NDC number is used to bill for this package of Pertzye pancrelipase 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]/1 Capsule, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pertzye 24000 [USP'U]/1; 90750 [USP'U]/1; 86250 [USP'U]this 59767-0024-02 Digestive 200 capsules $8.039 — Availability likely —
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.

What it looks like

Color blue / green / red / purple
ShapeCapsule
ImprintDCI;24
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.

🧪 Avoiding an ingredient? See Pancrelipase inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII F2O5O2OI9F
    A cellulose derivative made by chemically modifying plant fiber. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
  • UNII UF064M00AF
    Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 724L30Y2QR
    Ursodiol is a naturally occurring bile acid used in oral medications as an active pharmaceutical ingredient, not an excipient. However, if present as an inactive component, it may serve to solubilize other drugs or aid in formulation stability within the product.

8 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.

Manufacturer & labeler

LabelerDigestive Care, Inc.
FDA applicationBLA022175 (BLA)
Labeler code59767
First marketedJul 2017
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Digestive Care, Inc. labeler code 59767

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) PERTZYE 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 PERTZYE. When switching from another pancreatic enzyme product to PERTZYE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adults 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 of age and older.

1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age. 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 to be effective by fecal fat measures or improvement in malabsorption.

Pediatric Patients Birth to 12 Months: The recommended dosage is 4,000 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).

The 4,000 USP lipase unit capsule may be administered with applesauce via gastrostomy tube (14 French or larger). The contents of no more than two capsules may be administered at a time. Do not crush or chew PERTZYE capsules or capsule contents.

Consume sufficient liquids to ensure complete swallowing of PERTZYE. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months of age.

2.1Important Dosing Information PERTZYE is a mixture of enzymes including lipases, proteases, and amylases. PERTZYE 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 PERTZYE dose for a meal. Do not substitute other pancreatic enzyme products for PERTZYE.

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

2.2Recommended Dosage Adults 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. 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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Delayed-release capsules are available in the following strengths: 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI" 8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI" 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI" 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase in a two-piece hard gelatin capsule with a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI" Delayed-Release Capsules ( 3 ): 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase.

8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase. 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase. 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase.

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Fibrosing Colonopathy : 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 ) Irritation of the Oral Mucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 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 with use 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 a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE 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 and 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 PERTZYE 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 on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce).

The 4,000 USP lipase unit capsule may also be administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger. Do not crush or chew PERTZYE capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of PERTZYE 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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 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 reactions (≥ 10%) are: diarrhea, dyspepsia, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Digestive Care Inc. at 1-877-882-5950 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 clinical practice. The data described below reflect exposure to PERTZYE in 21 patients, aged 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis in a placebo-controlled clinical trial [see Clinical Studies (14) ] .

Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 10%) treated with PERTZYE at a higher rate than with placebo. Table 1. Adverse Reactions Reported in at least 2 PERTZYE-treated patients (≥10%) and at a higher rate than placebo-treated patients in a Clinical Trial of Adult and Pediatric Patients 8 Years of Age and Older with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis Adverse Reaction PERTZYE N=21 (%) Placebo N=24 (%) Diarrhea 10% 4% Dyspepsia 10% 4% Cough 10% 4%

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of PERTZYE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy, distal intestinal obstruction syndrome abdominal pain, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives, and pruritus Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash

👥 Use in Specific Populations ~2 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 population 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 PERTZYE and any potential adverse effects on the breastfed infant from PERTZYE or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14) ] .

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 PERTZYE 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 (2.1) and Warnings and Precautions (5.1) ] .

Crushing or chewing PERTZYE 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: 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 that 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) ] .

8.5Geriatric Use Clinical studies of PERTZYE 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.

🤰 Pregnancy 118 words ▾

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 population 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.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14) ] .

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 PERTZYE 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 (2.1) and Warnings and Precautions (5.1) ] .

Crushing or chewing PERTZYE 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: 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 that 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 PERTZYE 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 45 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 159 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 maltotriose 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 PERTZYE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14) ] .

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

🧬 Mechanism of Action 64 words ▾

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 maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PERTZYE (pancrelipase) delayed-release capsules, containing light tan/cream-colored delayed-release microspheres are supplied as follows: Strength Description Supplied As NDC Number 4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI" Bottles of 100 59767-004-01 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI" Bottles of 100 Bottles of 250 59767-008-01 59767-008-02 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI" Bottles of 100 Bottles of 250 59767-016-01 59767-016-02 24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase Two-piece hard gelatin capsule with a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI" Bottles of 80 Bottles of 200 59767-024-01 59767-024-02 Storage and Handling Store PERTZYE at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days.

PERTZYE hard gelatin capsules should be stored in a dry place in the original container or equivalent airtight container. After opening, keep the container tightly closed between uses to protect from moisture. PERTZYE is dispensed in bottles containing a desiccant.

📦 Storage and Handling 68 words ▾

Storage and Handling Store PERTZYE at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days. PERTZYE hard gelatin capsules should be stored in a dry place in the original container or equivalent airtight container. After opening, keep the container tightly closed between uses to protect from moisture. PERTZYE is dispensed in bottles containing a desiccant.

📋 Description ~2 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 microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows: 4,000 USP units of lipase ; 14,375 USP units of protease; and 15,125 USP units of amylase; delayed-release capsules have a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI".

The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 8,000 USP units of lipase ; 28,750 USP units of protease; and 30,250 USP units of amylase; delayed-release capsules have a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac, and ammonium hydroxide.

16,000 USP units of lipase ; 57,500 USP units of protease; and 60,500 USP units of amylase; delayed-release capsules have a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac. 24,000 USP units of lipase ; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI".

The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). 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 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) ] .

Dosage Advise the patient or caregiver to take or administer PERTZYE 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 to: Take PERTZYE with meals or snacks. Swallow capsules whole.

For 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). The 4,000 USP lipase unit capsule may also be administered with applesauce via gastrostomy tube 14 French or larger. For pediatric patients birth to 12 months of age, PERTZYE capsules can be opened, and the capsule contents sprinkled directly into the infant's mouth.

See the Instructions for Use for a description of all preparation and administration instructions. Consume sufficient liquids (juice, water, breast milk, or formula) and visually inspect an infant's mouth to ensure complete swallowing of PERTZYE capsules or capsule contents [see Warnings and Precautions (5.2) ] . Do not crush or chew PERTZYE capsules or capsule contents.

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

The desiccant packet should not be eaten or thrown away.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2024 MEDICATION GUIDE PERTZYE (pert-zye) (pancrelipase) delayed-release capsules What is the most important information I should know about PERTZYE?

PERTZYE may increase the risk 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 doctor gives you.

Call your doctor right away if you have any unusual or severe: stomach area (abdominal) pain bloating trouble passing stool (constipation) nausea vomiting diarrhea Take PERTZYE exactly as prescribed by your doctor. Do not take more PERTZYE than directed by your doctor. What is PERTZYE?

PERTZYE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. PERTZYE capsules contain a mixture of digestive enzymes including lipases, proteases and amylases from pig pancreas. PERTZYE is safe and effective in adults and children.

Before taking PERTZYE, tell your doctor about all of 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 PERTZYE passes into your breast milk.

Talk to your doctor about the best way to feed your baby if you take PERTZYE. Tell your doctor 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 doctor and pharmacist when you get a new medicine. How should I take PERTZYE? See the Instructions for Use at the end of this Medication Guide for detailed instructions about how to give PERTZYE by mouth and through a gastrostomy tube.

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

You should not switch PERTZYE with any other pancreatic enzyme product without first talking with your doctor. Do not take more capsules in a day than the number your doctor tells you to take (total daily dose). Always take PERTZYE with a meal or snack.

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

Do not crush or chew the PERTZYE capsules or their contents and do not hold the capsule or capsule contents in your mouth. Crushing or chewing the PERTZYE capsules may cause irritation in your mouth or change the way PERTZYE works in your body. Drink plenty of liquid to ensure complete swallowing of the PERTZYE capsules or PERTZYE capsule contents-food mixture.

Throw away the PERTZYE capsule contents-food mixture that is not used. Do not save this mixture for later use. If you miss a dose of PERTZYE, wait until your next meal or snack and take your prescribed dose.

Take your next dose at your usual time. Do not take two doses at one time. What are the possible side effects of PERTZYE?

See " What is the most important information I should know about PERTZYE? " Irritation of the inside of your mouth. This can happen if PERTZYE is not swallowed completely, is crushed or chewed, or is mixed in foods that are not recommended. Increase in blood uric acid levels (hyperuricemia).

This may… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 50 words ▾

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

🧬 Pharmacodynamics 42 words ▾

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 PERTZYE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14) ] .

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Adult and Pediatric Patients A randomized, double-blind, placebo-controlled, crossover study was conducted in 24 patients aged 8 to 43 years (mean age of 20 years) with exocrine pancreatic insufficiency due to cystic fibrosis. Patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units/kg/meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days. The mean lipase dosage during the treatment period was 1,565 lipase units/kg/meal and a controlled high-fat diet (approximately 2g fat/kg/day) was maintained throughout the study.

The length of exposure to PERTZYE during this study was 20 to 28 days, including the treatment period of 6 to 8 days, and the open label titration and transition periods of 7 to 10 days each. The efficacy analysis population included 21 patients who completed both double-blind treatment periods. Coefficient of Fat Absorption Endpoint and Results The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between PERTZYE and placebo treatment.

The CFA was determined by a 72-hour stool collection during both treatments, when both fat ingestion and excretion were measured. Mean CFA was 83% with PERTZYE treatment compared to 46% with placebo treatment. The mean difference in CFA was 36 percentage points in favor of PERTZYE treatment with 95% CI: (28, 45) and p<0.001.

Coefficient of Nitrogen Absorption Endpoint and Results The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient's CNA during placebo treatment was used as their no-treatment CNA value. Mean CNA was 79% with PERTZYE treatment compared to 47% with placebo treatment.

The mean difference in CNA was 32 percentage points in favor of PERTZYE treatment and this was a statistically significant change. There were no differences between pediatric patients and adults in the severity of pancreatic insufficiency (placebo response) or in the magnitude of the response to PERTZYE.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE PERTZYE (pert-zye) (pancrelipase) delayed-release capsules This Instructions for Use contains information on how to give PERTZYE by mouth and through a gastrostomy tube. Important Information You Need to Know Before Taking PERTZYE: Always take PERTZYE with a meal or snack. PERTZYE capsules should be swallowed whole.

Do not crush or chew the PERTZYE capsules or their contents, and do not hold the capsule or capsule contents in your mouth. Drink plenty of liquid to ensure complete swallowing of PERTZYE capsules or PERTZYE capsule contents-food mixture. Throw away the PERTZYE capsule contents-food mixture that is not used.

Do not save this mixture for later use. Giving PERTZYE to infants (Children from Birth to 12 Months of Age) by mouth: The two methods to give PERTZYE to Infants (Children from Birth to 12 Months of Age) are described below: a) Giving with Applesauce Before Breast or Formula Feeding Place about 2 teaspoons of applesauce, the kind found in baby food jars that you buy at the store, or other food recommended by your doctor, into a clean container. Carefully open the PERTZYE capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart.

Pour the capsule contents onto the food in the clean container. Throw away the empty PERTZYE capsule. Carefully mix the capsule contents evenly through the food.

Be careful not to crush the PERTZYE capsule contents when mixing. Give the PERTZYE capsule contents-food mixture to your infant right away. Give your infant 4 ounces (120 mL) of formula or breastfeed your infant right away .

Look in your infant's mouth to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents-food mixture left in your infant's mouth. b) Giving Directly into the Infant's Mouth Before Breast or Formula Feeding Carefully open the PERTZYE capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. Empty the capsule contents into your infant's mouth. Give your infant 4 ounces (120 mL) of formula or breastfeed right away.

Look in your infant's mouth to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents left in your infant's mouth. Throw away the empty PERTZYE capsule. Do not mix the PERTZYE capsule contents directly into a bottle of breast milk or formula.

Giving PERTZYE to children and adults by mouth: Swallow PERTZYE capsules whole and take them with enough liquid to swallow them right away. If you have trouble swallowing capsules, follow these instructions for taking PERTZYE with food: Place about 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. Carefully open the capsules that you will need for the prescribed dose by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart.

Pour the capsule contents onto the food in the clean container. Throw away the empty PERTZYE capsules. Carefully mix the capsule contents evenly through the food.

Be careful not to crush the PERTZYE capsule contents when mixing. Swallow all of the PERTZYE capsule contents-food mixture right away. Drink plenty of water or juice to make sure that all of the medicine is swallowed and there is no PERTZYE capsule contents-food mixture left in the mouth.

Giving PERTZYE through a gastrostomy tube: PERTZYE 4,000 lipase units capsule contents may be given through a gastrostomy tube that is size 14 French or larger. Do not give PERTZYE through a gastrostomy tube smaller than size 14 French. Do not give more than the contents of 2 PERTZYE 4,000 lipase units capsules through a gastrostomy tube at a time.

Give the PERTZYE capsule contents-food mixture right away after it is prepared. 1. Place at least 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container.

2. Carefully open 1 or 2 of the PERTZYE capsules, depending on your pre… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-008-01 100 Capsules NDC 59767-008-01 pancrelipase PERTZYE ® Rx Only Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 8,000 USP Units Protease 28,750 USP Units Amylase 30,250 USP Units Each delayed-release capsule contains pancrelipase in bicarbonate-buffered enteric-coated microspheres. This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-008-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-004-01 100 Capsules NDC 59767-004-01 pancrelipase PERTZYE ® Rx Only Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 4,000 USP Units Protease 14,375 USP Units Amylase 15,125 USP Units Each delayed-release capsule contains pancrelipase in bicarbonate-buffered enteric-coated microspheres. This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-004-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-016-01 100 Capsules NDC 59767-016-01 pancrelipase PERTZYE ® Rx Only Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 16,000 USP Units Protease 57,500 USP Units Amylase 60,500 USP Units Each delayed-release capsule contains pancrelipase in bicarbonate-buffered enteric-coated microspheres. This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - 59767-016-01

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label 80 Capsules NDC 59767-024-01 pancrelipase PERTZYE ® Rx Only Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 86,250 USP Units Amylase 90,750 USP Units Each delayed-release capsule contains pancrelipase in bicarbonate-buffered enteric-coated microspheres. This product is of porcine origin. No preservative.

PHARMACIST: Dispense the accompanying Medication Guide to each patient. PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
207
Units reimbursed last 4 qtrs
115.6K
Gross reimbursed last 4 qtrs
$910.6K
Avg / prescription
$4,398.91
Avg / unit
$7.8769
Latest quarter Q1 2026
49Rx
Medicaid pays / ea
$7.8769
gross reimbursed
vs
NADAC / ea
$8.0388
acquisition cost
=
Spread
−$0.1619
-2% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
74% FFS 26% MCO
Fee-for-service · 153 Rx Managed care · 54 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 83,660 units · 427 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 6,310 units · 16.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 25,631 units · 113 per 100k residents FL
Units reimbursed · per 100k residents
16.2427
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 427 /100k
2 Florida 113 /100k
3 California 16.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
80 capsules59767-0024-01 1,253 Rx · $5,240,138
200 capsules this page59767-0024-02 207 Rx · $910,574
20 capsules59767-0024-00 No Medicaid data
80 capsules59767-0024-99 No Medicaid data
Drug total (last 4 qtrs): 1,460 Rx · 785,062 units · $6,150,712 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 Pertzye — 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 Pertzye. 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
$1.75M
Claims incl. refills
418
Beneficiaries
229
Spend / beneficiary
$7,640.52
Spend / claim
$4,185.84
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.
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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.