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Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]/1 Capsule, Delayed Release, 100-count — NDC 73562-0114-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]/1 Capsule, Delayed Release, 100-count — NDC 73562-114-01 (Billing 73562-0114-01)

by Aimmune Therapeutics, Inc. · 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 100 capsules of Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]/1 Capsule, Delayed Release from Aimmune Therapeutics, Inc., marketed since Nov 2020 and currently FDA-listed; retail pharmacies pay about $16.20 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 73562-0114-01
🏷️ FDA NDC (as labeled) 73562-114-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$16.20 NADAC Per package$1,620.01 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $15.80/unit · Part D plans $16.28/unit — full pricing hub ↓
Main listing for product 73562-114 · Also comes in: 12 capsules 73562-114-12
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 73562-114-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73562 labeler · 114 product · 01 package
Package marketed since
Nov 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0373562115018, 0373562110013
Medicaid fills, this package
24,419 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) 73562-114-01
Product NDC 73562-114
11-digit billing NDC 73562011401
NCPDP billing unit EA — each (per item)
RxCUI 1594671, 1594673, 1595290, 1595292, 1595455, 1595457, 1595460, 1595462,
UNII YOJ58O116E, 3560D81V50, 8MYC33932O
UPC 0373562115018, 0373562110013
Application # BLA022210
SPL Set ID 7f16f2d4-8df6-4bd7-ac10-56994fa257b0
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-01
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Biologic (Purple Book) 351(a)

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

GPI-14 51200024006783
GPI class Zenpep
GCN Seq No 077963
GCN 44136
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 ZENPEP DR 40,000 UNIT CAPSULE
FDB brand name Zenpep
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077963
  • GCN: 44136
  • GPI-14 (Medi-Span): 51200024006783
  • HICL (First Databank): 008060
  • AHFS class code: 56:16.00.00
  • RxCUI (RxNorm): 1594671
Why two NDCs? The FDA registers this code as 73562-114-01 — 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 → 73562-0114-01. 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 ZENPEP DR 40,000 UNIT CAPSULE Ingredient Lipase/Protease/Amylase (Pork)
📖 What it is MedlinePlus · NLM

Pancrelipase capsules are used to improve digestion of food in infants, children, and adults who have pancreatic insufficiency (a condition in which the pancreas does not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food). Pancrelipase tablets are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who cannot digest food normally because they have chronic...

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $16.200 $1,620.01 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $15.80 $1,580.28 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $16.28 $1,628.35 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Dec 2023 Jun 2026 Sep 2026 $16.210 $14.130
▲ Up 14% over the last 9 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
73562-0114-01 You're viewing this Main listing 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE $16.20 / ea $1,620.01 2020-11-01 — Active
73562-0114-12 73562-114-12 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE Sample — — 2020-11-01 — Active

You're viewing the largest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, delayed release in 1 bottle.
How does this package differ from NDC 73562-0114-12?
Both are Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]/1 Capsule, Delayed Release — the drug itself is identical. This page's package is the 100-count one, while NDC 73562-0114-12 is the 12 capsules package.
What NDC number is used to bill for this package of Zenpep pancrelipase lipase, pancrelipase protease, pancrelipase amylase 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [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
Zenpep 40000 [USP'U]/1; 126000 [USP'U]/1; 168000 [USP'U]this 73562-0114-01 Aimmune 100 capsules $16.200 — 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

🏛️
2009
First FDA approval
Aug 2009
📍
2026
Currently FDA-listed
17 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.

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 White / Yellow / Red / Green / Blue / Orange
ShapeCapsule
ImprintAPTALIS;60
Size22 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII 8LDD2V82F5
    A plant-derived polymer that forms a protective coating around tablets or capsules. It delays release of the medication until it reaches the small intestine, protecting sensitive ingredients and improving how the body absorbs them.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 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.

10 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

LabelerAimmune Therapeutics, Inc.
FDA applicationBLA022210 (BLA)
Labeler code73562
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio11 products on file

More NDCs from Aimmune Therapeutics, Inc. labeler code 73562

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ZENPEP ® 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 ) ZENPEP 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 ZENPEP. When switching from another pancreatic enzyme product to ZENPEP, 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 of age and older.

1,000 lipase units/kg/meal for pediatric patients greater than 12 months of age to less than 4 years of age. Titrate 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 in 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, pears).

Do not crush or chew ZENPEP capsules or capsule contents. Consume sufficient liquids to ensure complete swallowing of ZENPEP. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months.

( 2.3 )

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

When switching from another pancreatic enzyme product to ZENPEP, 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. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months of age to less than 4 years of age. If signs and symptoms of malabsorption persist, increase the dosage.

Titrate to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or less than 4,000 lipase units/grams of fat ingested/day. Higher dosages may be administered if they are documented to be effective b… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~2 min read ▾

3 DOSAGE FORMS AND STRENGTHS Delayed-release capsules are available in the following strengths: 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase in a two‑piece hypromellose capsule with a white opaque cap and white opaque body, and red imprint with "APTALIS 3" 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase in a two‑piece hypromellose capsule with a white opaque cap and white opaque body, and blue imprint with "APTALIS 5" 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase in a two-piece hypromellose capsule with a yellow opaque cap and white opaque body, and blue imprint with "APTALIS 10" 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase in a two-piece hypromellose capsule with a red opaque cap and white opaque body, and blue imprint with "APTALIS 15" 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase in a two-piece hypromellose capsule with a green opaque cap and white opaque body, and blue imprint with "APTALIS 20" 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase in a two-piece hypromellose capsule with a blue opaque cap and white opaque body, and blue imprint with "APTALIS 25" 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase in a two-piece hypromellose capsule with an orange opaque cap and white opaque body, and blue imprint with "APTALIS 40" 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase.

Capsules have a powder blue opaque cap with two black stripes and white opaque body, black imprint with "APTALIS 60 " Delayed-Release Capsules ( 3 ): 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase 60,000 USP units of lipase; 189,600 USP units of protease; and 252,600 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. ( 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 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 ZENPEP 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 ZENPEP 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., commercially available preparations of applesauce, bananas or pears).

Do not crush or chew ZENPEP capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of ZENPEP 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 w… [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 (≥6%) are: headache, contusion, cough, and early satiety.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) 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 ZENPEP in 53 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials conducted [see Clinical Studies (14) ] . In both trials, ZENPEP was administered at dosages of approximately 5,000 lipase units/kg/day for 19 to 42 days.

Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 adult and pediatric patients, aged 7 to 23 years. Adverse reactions that were reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than in placebo-treated patients in Study 1 are shown in Table 1. Table 1: Adverse Reactions Reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than placebo-treated patients. in a Clinical Trial of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Study 1) Adverse Reaction ZENPEP N=34 n (%) Placebo N=32 n (%) Headache 5 (15%) 0 Contusion 2 (6%) 0 Cough 2 (6%) 0 Early Satiety 2 (6%) 0 Study 2 was an open-label, uncontrolled study of ZENPEP in 19 pediatric patients aged 1 to 6 years.

The most commonly reported adverse reactions were gastrointestinal, including abdominal pain and steatorrhea. The type and incidence of adverse reactions in Studies 1 and 2 were similar between pediatric patients and adults.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZENPEP 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 and distal intestinal obstruction syndrome abdominal distension, abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives and pruritis Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash

👥 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 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 ZENPEP and any potential adverse effects on the breastfed infant from ZENPEP or from the underlying maternal conditions.

8.4Pediatric Use The safety and effectiveness of ZENPEP for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of ZENPEP for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 7 to 17 years of age (Study 1) along with supportive data from an open-label, single arm study in 19 pediatric patients 1 to 6 years of age (Study 2). Both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis.

The safety in pediatric patients in Studies 1 and 2 were 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 ZENPEP 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 ZENPEP 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 ZENPEP 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 ZENPEP for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of ZENPEP for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 7 to 17 years of age (Study 1) along with supportive data from an open-label, single arm study in 19 pediatric patients 1 to 6 years of age (Study 2). Both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis.

The safety in pediatric patients in Studies 1 and 2 were 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 ZENPEP 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 ZENPEP 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 ZENPEP 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 monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch 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 ZENPEP 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 ZENPEP are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of ZENPEP are not substrates of CYP enzymes or transporters. CYP enzymes or transporters 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 monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch 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.

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

16 HOW SUPPLIED/STORAGE AND HANDLING ZENPEP (pancrelipase) delayed-release capsules containing light, brown-colored delayed-release pancrelipase are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 10,000 USP units of protease; 14,000 units of amylase two-piece hypromellose capsule with white opaque cap and white body with a red radial print and printed with "APTALIS 3" Bottles of 100 73562-113-01 5,000 USP units of lipase; 17,000 USP units of protease; 24,000 units of amylase two-piece hypromellose capsule with a white opaque cap and white body with a blue radial print and printed with "APTALIS 5" Bottles of 100 73562-115-01 10,000 USP units of lipase; 32,000 units of protease; 42,000 units of amylase two-piece hypromellose capsule with a yellow opaque cap and white body with a blue radial print and printed with "APTALIS 10" Bottles of 100 73562-110-01 15,000 USP units of lipase; 47,000 units of protease; 63,000 units of amylase two-piece hypromellose capsule with a red opaque cap and white body with a blue radial print and printed with "APTALIS 15" Bottles of 100 73562-111-01 20,000 USP units of lipase; 63,000 units of protease; 84,000 units of amylase two-piece hypromellose capsule with a green opaque cap and white body with a blue radial print and printed with "APTALIS 20" Bottles of 100 73562-112-01 25,000 USP units of lipase; 79,000 units of protease; 105,000 units of amylase two-piece hypromellose capsule with a blue opaque cap and white body with a blue radial print and printed with "APTALIS 25" Bottles of 100 73562-116-01 40,000 USP units of lipase; 126,000 units of protease; 168,000 units of amylase two-piece hypromellose capsule with an orange opaque cap and white body with a blue radial print and printed with "APTALIS 40" Bottles of 100 73562-114-01 60,000 USP units of lipase; 189,600 units of protease; 252,600 units of amylase two-piece hypromellose capsule with powder blue opaque cap with two black stripes and white body with a black radial print and printed with "APTALIS 60 " Bottles of 100 73562-117-01 Storage and Handling Original container: Store at room temperature, 20°C to 25°C (68°F to 77°F) and protect from moisture.

Brief excursions permitted to 15°C to 40°C (59°F to104°F) for 24 hours. After opening, keep bottle tightly closed between uses to protect from moisture. Zenpep is supplied in bottles containing a desiccant.

Repackaged HDPE container: Dispense in tight container (USP). Store at up to 30°C (86°F) for up to 6 months and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days.

Protect from moisture. After opening, keep bottle tightly closed between uses to protect from moisture.

📦 Storage and Handling 104 words ▾

Storage and Handling Original container: Store at room temperature, 20°C to 25°C (68°F to 77°F) and protect from moisture. Brief excursions permitted to 15°C to 40°C (59°F to104°F) for 24 hours. After opening, keep bottle tightly closed between uses to protect from moisture.

Zenpep is supplied in bottles containing a desiccant. Repackaged HDPE container: Dispense in tight container (USP). Store at up to 30°C (86°F) for up to 6 months and protect from moisture.

Brief excursions permitted to 15°C to 40°C (59°F to 104°F) for up to 30 days. Protect from moisture. After opening, keep bottle tightly closed between uses to protect from moisture.

📋 Description ~3 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 pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1 .

8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2 . 2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows: 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint "APTALIS 3". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water.

The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint "APTALIS 5". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water.

The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint "APTALIS 10". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide.

The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint "APTALIS 15". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water.

The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint "APTALIS 20". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide.

The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint "APTALIS 25". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water.

The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with "APTALIS 40". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide.

The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with "APTALIS 60 " The shells contain FD&C Blue #1, hypromellose, and titanium oxide.

The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, 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) ] . Dosage Advise the patient or caregiver to take ZENPEP 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 ZENPEP with meals or snacks. Swallow capsules whole. For adult and pediatric patients who are unable to swallow intact capsules, the capsule contents may be sprinkled on a small amount of acidic soft food with a pH of 4.5 or less (e.g., commercially available preparations of applesauce, bananas, or pears).

For pediatric patients birth to 12 months of age, ZENPEP 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 ZENPEP capsules or capsule contents [see Warnings and Precautions (5.2) ]. Do not crush or chew ZENPEP capsules or capsule contents.

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

Keep the desiccant in the bottle, if present. 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 07/2025 MEDICATION GUIDE ZENPEP ® (ZEN-pep) (pancrelipase) delayed-release capsules, for oral use What is the most important information I should know about ZENPEP?

ZENPEP 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 doctor gave you.

Call your doctor 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 ZENPEP exactly as prescribed by your doctor. Do not take more ZENPEP than directed by your doctor. What is ZENPEP?

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

Before taking ZENPEP, tell your doctor 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 ZENPEP passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take ZENPEP.

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 ZENPEP? Take ZENPEP 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 distention, bloating, fatty stools, or weight loss.

Your dose may need to be changed. You should not switch ZENPEP with any other pancreatic enzyme product without first talking to your doctor. Do not take more capsules in a day than the number your doctor tells you (total daily dose).

Always take ZENPEP 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. ZENPEP capsules should be swallowed whole.

Do not crush or chew the ZENPEP capsules or its contents and do not hold the capsule contents in your mouth. Crushing or chewing the ZENPEP capsules may cause irritation in your mouth or change the way ZENPEP works in your body. Giving ZENPEP to Adults and Children 12 Months of Age and Older: Swallow ZENPEP capsules whole and take them with enough liquid (water or juice) to swallow them right away.

If you have trouble swallowing capsules, open the capsules and sprinkle the entire contents on a small amount of acidic soft food such as applesauce, bananas or pears. Ask your doctor about other foods you can mix with ZENPEP. If you sprinkle ZENPEP on food, swallow it right after you mix it.

Do not store ZENPEP that is mixed with food. Swallow the ZENPEP and food mixture right away followed with water or juice. Make sure the medicine is swallowed completely.

If you forget to take ZENPEP, call your doctor or wait until your next meal and take your usual number of capsules. Do not make up for missed doses. Take your next dose at the usual time.

Giving ZENPEP to Infants (Children from Birth to 12 Months of Age): The 2 ways to give ZENPEP to infants (children from birth to 12 months of age), which are described below: a) Giving with an Acidic So… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 50 words ▾

12.3Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from ZENPEP are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of ZENPEP are not substrates of CYP enzymes or transporters. CYP enzymes or transporters 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 ZENPEP 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 7 Years of Age and Older Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 patients, aged 7 to 23 years, with exocrine pancreatic insufficiency due to cystic fibrosis. The final analysis population was limited to 32 patients, who completed both double-blind treatment periods, and were included in the efficacy analysis population. Patients were randomized to receive ZENPEP or matching placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 7 days.

The mean exposure to ZENPEP during this study, including titration period and open label transition, was 30 days. The mean dosage during the controlled treatment periods ranged from a mean dose of 3,900 lipase units/kg/day to 5,700 lipase units/kg/day. All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.

The population was nearly evenly distributed in biological sex, and approximately 96% of patients were White. Coefficient of Fat Absorption Endpoint and Results The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA) between ZENPEP and placebo treatment. The CFA was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.

Each patient's CFA during placebo treatment was used as their no-treatment CFA value. Mean CFA was 88% with ZENPEP treatment compared to 63% with placebo treatment. The mean difference in CFA was 26 percentage points in favor of ZENPEP treatment with 95% Confidence Interval of (19, 32) and p≤0.001.

Subgroup analyses of the CFA results showed that mean change in CFA was greater in patients with lower no-treatment (placebo) CFA values than in patients with higher no-treatment (placebo) CFA values. There were similar responses to ZENPEP by age and biological sex. Pediatric Patients 1 to 6 Years of Age Study 2 was an open-label, uncontrolled study of 19 pediatric patients, aged 1 to 6 years (mean age 4 years), with exocrine pancreatic insufficiency due to cystic fibrosis.

Approximately half of the patients were aged 1 to 3 years. Study 2 compared a measurement of fat malabsorption, spot fecal fat testing, before (while receiving therapy with another pancreatic enzyme product) and after oral administration of ZENPEP capsules with each meal or snack. After a 4 to 14 day screening period during which patients remained on their current pancreatic enzyme product, patients were switched to ZENPEP at individually titrated dosages ranging between 2,300 and 10,000 lipase units/kg/day (not to exceed 2,500 lipase units/kg/meal) for 14 days.

The mean ZENPEP dosage was approximately 5,000 lipase unit/kg/day. There was no wash-out period. Overall, patients showed similar control of fat malabsorption by spot fecal fat testing when switched from their current pancreatic enzyme product to ZENPEP treatment at a similar dosage.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-113-01 NDC 73562-113-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 3,000 USP units Protease 10,000 USP units Amylase 14,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-113-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-115-01 NDC 73562-115-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 5,000 USP units Protease 17,000 USP units Amylase 24,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-115-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-110-01 NDC 73562-110-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 10,000 USP units Protease 32,000 USP units Amylase 42,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-110-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-111-01 NDC 73562-111-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 15,000 USP units Protease 47,000 USP units Amylase 63,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-111-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-112-01 NDC 73562-112-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 20,000 USP units Protease 63,000 USP units Amylase 84,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-112-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-116-01 NDC 73562-116-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 25,000 USP units Protease 79,000 USP units Amylase 105,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-116-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-114-01 NDC 73562-114-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 40,000 USP units Protease 126,000 USP units Amylase 168,000 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-114-01

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-117-01 NDC 73562-117-01 pancrelipase Zenpep ® DELAYED-RELEASE CAPSULES Rx only DOSE BY LIPASE UNITS: Lipase 60,000 USP units Protease 189,600 USP units Amylase 252,600 USP units Dispense enclosed Medication Guide to each patient 100 Delayed-Release Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label - NDC 73562-117-01

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
24.4K
Units reimbursed last 4 qtrs
5M
Gross reimbursed last 4 qtrs
$78.65M
Avg / prescription
$3,220.98
Avg / unit
$15.8028
Latest quarter Q1 2026
5.8KRx
Medicaid pays / ea
$15.8028
gross reimbursed
vs
NADAC / ea
$16.2001
acquisition cost
=
Spread
−$0.3973
-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 ⓘ
61% FFS 39% MCO
Fee-for-service · 14,850 Rx Managed care · 9,569 Rx
State Medicaid map
Alaska: 1,310 units · 179 per 100k residents AK Maine: 40,400 units · 2,896 per 100k residents ME Washington: 78,190 units · 1,001 per 100k residents WA Idaho: 51,506 units · 2,623 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 20,830 units · 363 per 100k residents MN Wisconsin: 204,704 units · 3,464 per 100k residents WI Michigan: 115,626 units · 1,152 per 100k residents MI New York: 1,137,924 units · 5,814 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 29,980 units · 708 per 100k residents OR Nevada: 32,700 units · 1,024 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 26,410 units · 824 per 100k residents IA Illinois: 211,099 units · 1,682 per 100k residents IL Indiana: 115,800 units · 1,688 per 100k residents IN Ohio: 249,212 units · 2,115 per 100k residents OH Pennsylvania: 146,174 units · 1,128 per 100k residents PA New Jersey: 79,084 units · 851 per 100k residents NJ Massachusetts: 49,555 units · 708 per 100k residents MA California: 598,461 units · 1,536 per 100k residents CA Utah: 51,962 units · 1,521 per 100k residents UT Colorado: 188,206 units · 3,202 per 100k residents CO Nebraska: 16,459 units · 832 per 100k residents NE Missouri: 85,531 units · 1,380 per 100k residents MO Kentucky: 68,790 units · 1,520 per 100k residents KY West Virginia: 47,939 units · 2,708 per 100k residents WV Virginia: 96,858 units · 1,111 per 100k residents VA Maryland: 99,346 units · 1,608 per 100k residents MD Connecticut: 47,138 units · 1,303 per 100k residents CT Rhode Island: 5,863 units · 535 per 100k residents RI Arizona: 176,446 units · 2,374 per 100k residents AZ New Mexico: no data reported NM Kansas: 4,800 units · 163 per 100k residents KS Arkansas: 18,825 units · 614 per 100k residents AR Tennessee: 88,410 units · 1,241 per 100k residents TN North Carolina: 211,281 units · 1,950 per 100k residents NC South Carolina: 40,378 units · 751 per 100k residents SC Delaware: no data reported DE Oklahoma: 67,730 units · 1,671 per 100k residents OK Louisiana: 53,926 units · 1,179 per 100k residents LA Mississippi: 12,530 units · 426 per 100k residents MS Alabama: 25,090 units · 491 per 100k residents AL Georgia: 92,376 units · 838 per 100k residents GA D.C.: no data reported DC Hawaii: 15,818 units · 1,102 per 100k residents HI Texas: 83,808 units · 275 per 100k residents TX Florida: 188,683 units · 835 per 100k residents FL
Units reimbursed · per 100k residents
1635,814
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 5,814 /100k
2 Wisconsin 3,464 /100k
3 Colorado 3,202 /100k
4 Maine 2,896 /100k
5 West Virginia 2,708 /100k
6 Idaho 2,623 /100k
7 Arizona 2,374 /100k
8 Ohio 2,115 /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.
100 capsules this page73562-0114-01 24,419 Rx · $78,653,007
12 capsules73562-0114-12 No Medicaid data
Drug total (last 4 qtrs): 24,419 Rx · 4,977,158 units · $78,653,007 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 Zenpep — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Zenpep. 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
$176.65M
Claims incl. refills
65.2K
Beneficiaries
36K
Spend / beneficiary
$4,901.72
Spend / claim
$2,710.36
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.