FDA.reportPublic FDA data

PERTZYE

Product NDC
59767-008
Requested package NDC
59767-008-01
11-digit product format
597670008
Labeler code
59767
Product ID
59767-008_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
2012-05-17
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
30250; 8000; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59767-00859767-008-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE LIPASE30250 [USP'U]/1
PANCRELIPASE AMYLASE8000 [USP'U]/1
PANCRELIPASE PROTEASE28750 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3560D81V50Internal UNII lookup
YOJ58O116EInternal UNII lookup
8MYC33932OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1294122Internal RxNorm lookup
1294128Internal RxNorm lookup
1294481Internal RxNorm lookup
1294483Internal RxNorm lookup
1543004Internal RxNorm lookup
1543006Internal RxNorm lookup
1929116Internal RxNorm lookup
1929118Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
481eec00-9abf-11dd-b71c-0002a5d5c51bAvailable on FDA.report

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
59767-008-00PERTZYE20 in 1 BOTTLECAPSULE, DELAYED RELEASE2022
59767-008-01PERTZYE100 in 1 BOTTLECAPSULE, DELAYED RELEASE10022
59767-008-02PERTZYE250 in 1 BOTTLECAPSULE, DELAYED RELEASE25022
59767-008-99PERTZYE100 in 1 BOTTLECAPSULE, DELAYED RELEASE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59767-008-01EA - Each59767-0089c89bd90-3671-4302-940e-adf9b4990f6d12012-07-24
59767-008-02EA - Each59767-008bb1a3692-38b1-46c1-9fc3-caff3d2b542e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANCRELIPASE AMYLASEACTIVE INGREDIENTYOJ58O116EPERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12
PANCRELIPASE LIPASEACTIVE INGREDIENT8MYC33932OPERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12
PANCRELIPASE PROTEASEACTIVE INGREDIENT3560D81V50PERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12
PANCRELIPASE AMYLASEACTIVE MOIETYYOJ58O116EPERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12
PANCRELIPASE LIPASEACTIVE MOIETY8MYC33932OPERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12
PANCRELIPASE PROTEASEACTIVE MOIETY3560D81V50PERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59767-008PERTZYE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [DIGESTIVE CARE, INC.]22Current NDC, Legacy NDC, 4 package rows20240315_481eec00-9abf-11dd-b71c-0002a5d5c51b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PERTZYEPANCRELIPASEDigestive Care, Inc.481eec00-9abf-11dd-b71c-0002a5d5c51b2024-03-11Warnings, Adverse reactionsExact identifier
application number: BLA022175
ndc (package): 59767-008-01
ndc (product): 59767-008
ndc11 (package): 59767000801

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022175Pertzyepancrelipase351(a)Rx2026-07-01

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
59767-008-0159767000801100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-008-01) 2012-05-170000-00-00NoNoCurrent