FDA.reportPublic FDA data

Pancreatic Enzyme Concentrate

Manufacturer
Covetrus North America | Alberta Veterinary Laboratories | Scientific Protein Laboratories LLC
Effective date
2026-05-14
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:47:00

Label at a glance#

ProductPancreatic Enzyme Concentrate
Active ingredientPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
Label structure8 sections

Label contents#

Full prescribing information#

Tablets

SPL UNCLASSIFIED SECTION

For use in dogs and cats.

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For use in animals only

Keep out of reach of children

Description:

DESCRIPTION SECTION

This product is a pancreatic enzyme concentrate of porcine origin.

Indications:

INDICATIONS & USAGE SECTION

For use as a digestive aid in replacement therapy where digestion of protein, carbohydrate, and fat is inadequate due to exocrine pancreatic insufficiency in dogs and cats.

Each tablet contains a minimum of:

DOSAGE FORMS & STRENGTHS SECTION

Lipase        9,000 USP units

Protease   57,000 USP units

Amylase   64,000 USP units

Dosage:

DOSAGE & ADMINISTRATION SECTION

Pancreatic Enzyme Concentrate is administered before each meal.  Consult with your veterinarian for the appropriate dose based on the severity of the condition and weight of the animal.

Average dose/meal:

Dogs: 2 - 3 tablets

Cats: 1/2 - 1 tablet

Precautions:

PRECAUTIONS SECTION

Discontinue use in animals with symptoms of sensitivity or allergy. Consult with your veterinarian regarding dosing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pancreatic Enzyme Concentrate Tablets - 100 Count

image descriptionimage description

Pancreatic Enzyme Concentrate Tablets - 500 Count 

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421001lipase 9,000 UNT / amylase 64,000 UNT / protease 57,000 UNT Oral TabletPSN3
1421001amylase 64000 UNT / lipase 9000 UNT / protease 57000 UNT Oral TabletSCD3
1421001amylase 64,000 UNT / protease 57,000 UNT / lipase 9,000 UNT Oral TabletSY3
1421001amylases 64,000 UNT / endopeptidases 57,000 UNT / lipase 9000 UNT Oral TabletSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840066515816GTIN-13: 0840066515816
EAN-13: 0840066515816
GTIN-12: 840066515816
UPC-A: 840066515816
GTIN storage (14 digits): 00840066515816		PancreaticEnzyme_Tablets_100ct_Jar.jpg
BarcodeEAN-130840066515847GTIN-13: 0840066515847
EAN-13: 0840066515847
GTIN-12: 840066515847
UPC-A: 840066515847
GTIN storage (14 digits): 00840066515847		PancreaticEnzyme_Tablets_500ct_Jar.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-7046-1Pancreatic Enzyme Concentrate100 in 1 PACKAGETABLET1003
11695-7046-4Pancreatic Enzyme Concentrate500 in 1 PACKAGETABLET5003

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-704611695-7046-1, 11695-7046-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANCRELIPASE LIPASE8MYC33932OACTIB
PANCRELIPASE PROTEASE3560D81V50ACTIB
PANCRELIPASE AMYLASEYOJ58O116EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-11monthly-update2026-06-03 17:55:54

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.