NDC 59767-008

PERTZYE

Pancrelipase

PERTZYE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Digestive Care, Inc.. The primary component is Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease.

Product ID59767-008_1bbfbfb5-d5da-4cbe-aa2f-80afec77e165
NDC59767-008
Product TypeHuman Prescription Drug
Proprietary NamePERTZYE
Generic NamePancrelipase
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2012-05-17
Marketing CategoryBLA / NDA
Application NumberBLA022175
Labeler NameDigestive Care, Inc.
Substance NamePANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active Ingredient Strength30250 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59767-008-01

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-008-01)
Marketing Start Date2012-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59767-008-01 [59767000801]

PERTZYE CAPSULE, DELAYED RELEASE
Marketing CategoryBLA
Application NumberBLA022175
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17

NDC 59767-008-02 [59767000802]

PERTZYE CAPSULE, DELAYED RELEASE
Marketing CategoryBLA
Application NumberBLA022175
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17

NDC 59767-008-99 [59767000899]

PERTZYE CAPSULE, DELAYED RELEASE
Marketing CategoryBLA
Application NumberBLA022175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-08
Marketing End Date2014-07-07

Drug Details

Active Ingredients

IngredientStrength
PANCRELIPASE LIPASE8000 [USP'U]/1

OpenFDA Data

SPL SET ID:481eec00-9abf-11dd-b71c-0002a5d5c51b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1929118
  • 1543004
  • 1543006
  • 1929116
  • 1294128
  • 1294481
  • 1294483
  • 1294122
    • UPC Code
  • 0359767016015
  • 0359767008010

    • NDC Crossover Matching brand name "PERTZYE" or generic name "Pancrelipase"

    NDCBrand NameGeneric Name
    59767-004PERTZYEPERTZYE
    59767-008PERTZYEPERTZYE
    59767-024PERTZYEPERTZYE
    59767-016PERTZYEPERTZYE
    0032-1203CreonPancrelipase
    0032-1206CreonPancrelipase
    0032-1212CreonPancrelipase
    0032-1224CreonPancrelipase
    0032-3016CreonPancrelipase
    17856-1206CreonPancrelipase
    17856-1212CreonPancrelipase
    17856-1224CreonPancrelipase
    50458-341PANCREAZEPANCRELIPASE
    50458-342PANCREAZEPANCRELIPASE
    50458-343PANCREAZEPANCRELIPASE
    50458-346PANCREAZEPANCRELIPASE
    50458-347PANCREAZEPANCRELIPASE
    58914-112ViokacePancrelipase
    58914-117ViokacePancrelipase
    42865-300ZENPEPpancrelipase
    42865-302ZENPEPpancrelipase
    42865-303ZENPEPpancrelipase
    42865-304ZENPEPpancrelipase
    42865-305ZENPEPpancrelipase
    42865-306ZENPEPpancrelipase
    42865-307ZENPEPpancrelipase

    Trademark Results [PERTZYE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PERTZYE
    PERTZYE
    77791013 4218154 Live/Registered
    Digestive Care, Inc.
    2009-07-28
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