FDA.reportPublic FDA data

PERTZYE

Product NDC
59767-024
11-digit product format
597670024
Labeler code
59767
Product ID
59767-024_2ae80639-0555-49c6-bae7-00f43983e614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pancrelipase
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Digestive Care, Inc.
Application
BLA022175
Marketing category
BLA
Marketing start
2017-07-13
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
90750; 24000; 86250 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PERTZYE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE AMYLASE90750 [USP'U]/1
PANCRELIPASE LIPASE24000 [USP'U]/1
PANCRELIPASE PROTEASE86250 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3560D81V50, YOJ58O116E, 8MYC33932O
Rxcui1294122, 1294128, 1294481, 1294483, 1543004, 1543006, 1929116, 1929118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59767-024-00PERTZYE20 in 1 BOTTLECAPSULE, DELAYED RELEASE2022
59767-024-01PERTZYE80 in 1 BOTTLECAPSULE, DELAYED RELEASE8022
59767-024-02PERTZYE200 in 1 BOTTLECAPSULE, DELAYED RELEASE20022
59767-024-99PERTZYE80 in 1 BOTTLECAPSULE, DELAYED RELEASE8022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59767-024PERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]22Current NDC, Legacy NDC, 4 package rows20240315_481eec00-9abf-11dd-b71c-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294122lipase 16,000 UNT / amylase 60,500 UNT / protease 57,500 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929116lipase 24,000 UNT / amylase 90,750 UNT / protease 86,250 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543004lipase 4000 UNT / amylase 15,125 UNT / protease 14,375 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294481lipase 8000 UNT / amylase 30,250 UNT / protease 28,750 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294128Pertzye 16,000 UNT / 60,500 UNT / 57,500 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929118Pertzye 24,000 UNT / 90,750 UNT / 86,250 UNT / Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543006Pertzye 4000 UNT / 15,125 UNT / 14,375 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294483Pertzye 8000 UNT / 30,250 UNT / 28,750 UNT Delayed Release Oral CapsulePSN481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543006amylase 15125 UNT / lipase 4000 UNT / protease 14375 UNT Delayed Release Oral Capsule [Pertzye]SBD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294483amylase 30250 UNT / lipase 8000 UNT / protease 28750 UNT Delayed Release Oral Capsule [Pertzye]SBD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294128amylase 60500 UNT / lipase 16000 UNT / protease 57500 UNT Delayed Release Oral Capsule [Pertzye]SBD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929118amylase 90750 UNT / lipase 24000 UNT / protease 86250 UNT Delayed Release Oral Capsule [Pertzye]SBD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543004amylase 15125 UNT / lipase 4000 UNT / protease 14375 UNT Delayed Release Oral CapsuleSCD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294481amylase 30250 UNT / lipase 8000 UNT / protease 28750 UNT Delayed Release Oral CapsuleSCD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294122amylase 60500 UNT / lipase 16000 UNT / protease 57500 UNT Delayed Release Oral CapsuleSCD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929116amylase 90750 UNT / lipase 24000 UNT / protease 86250 UNT Delayed Release Oral CapsuleSCD481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543004amylase 15,125 UNT / lipase 4000 UNT / protease 14,375 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294481amylase 30,250 UNT / lipase 8,000 UNT / protease 28,750 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294122amylase 60,500 UNT / lipase 16,000 UNT / protease 57,500 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929116amylase 90,750 UNT / lipase 24,000 UNT / protease 86,250 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543004amylases 15,125 UNT / endopeptidases 14,375 UNT / lipase 4000 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294481amylases 30,250 UNT / endopeptidases 28,750 UNT / lipase 8000 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294122amylases 60,500 UNT / endopeptidases 57,500 UNT / lipase 16,000 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929116amylases 90,750 UNT / endopeptidases 86,250 UNT / lipase 24,000 UNT Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543006Pertzye (amylase 15,125 UNT / lipase 4000 UNT / protease 14,375 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294483Pertzye (amylase 30,250 UNT / lipase 8,000 UNT / protease 28,750 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294128Pertzye (amylase 60,500 UNT / lipase 16,000 UNT / protease 57,500 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929118Pertzye (amylase 90,750 UNT / lipase 24,000 UNT / protease 86,250 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1543006Pertzye (amylases 15,125 UNT / endopeptidases 14,375 UNT / lipase 4000 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294483Pertzye (amylases 30,250 UNT / endopeptidases 28,750 UNT / lipase 8000 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1294128Pertzye (amylases 60,500 UNT / endopeptidases 57,500 UNT / lipase 16,000 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22
1929118Pertzye (amylases 90,750 UNT / endopeptidases 86,250 UNT / lipase 24,000 UNT) Delayed Release Oral CapsuleSY481eec00-9abf-11dd-b71c-0002a5d5c51b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59767-024-005976700240020 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-00) 2017-07-13YesNoCurrent
59767-024-015976700240180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-01) 2017-07-130000-00-00NoNoCurrent
59767-024-0259767002402200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-02) 2017-07-130000-00-00NoNoCurrent
59767-024-995976700249980 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-024-99) 2017-07-13YesNoCurrent