NDC 50458-343

PANCREAZE

Pancrelipase

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

Product ID50458-343_84df27aa-7ea7-11e8-b709-c19a9d46d017
NDC50458-343
Product TypeHuman Prescription Drug
Proprietary NamePANCREAZE
Generic NamePancrelipase
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-04-12
Marketing End Date2019-08-31
Marketing CategoryNDA / NDA
Application NumberNDA022523
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NamePANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
Active Ingredient Strength16800 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC Exclude FlagN

Packaging

NDC 50458-343-60

1 BOTTLE, GLASS in 1 CARTON (50458-343-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS
Marketing Start Date2010-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-343-60 [50458034360]

PANCREAZE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022523
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-12
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
PANCRELIPASE LIPASE16800 [USP'U]/1

OpenFDA Data

SPL SET ID:e1431edd-0fc5-4ebc-8c10-53deb0db0d23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806926
  • 1806924
  • 1806931
  • 1806921
  • 1806919
  • 1806966
  • 1806929
  • 1806964
  • 1806953
  • 1806955
    • UPC Code
  • 0350458341607

    • Medicade Reported Pricing

    50458034360 PANCREAZE DR 16,800 UNIT CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "PANCREAZE" or generic name "Pancrelipase"

    NDCBrand NameGeneric Name
    50458-341PANCREAZEPANCRELIPASE
    50458-342PANCREAZEPANCRELIPASE
    50458-343PANCREAZEPANCRELIPASE
    50458-346PANCREAZEPANCRELIPASE
    50458-347PANCREAZEPANCRELIPASE
    62541-405PANCREAZEPANCREAZE
    62541-404PANCREAZEPANCREAZE
    62541-401PANCREAZEPANCREAZE
    62541-402PANCREAZEPANCREAZE
    62541-403PANCREAZEPANCREAZE
    0032-1203CreonPancrelipase
    0032-1206CreonPancrelipase
    0032-1212CreonPancrelipase
    0032-1224CreonPancrelipase
    0032-3016CreonPancrelipase
    17856-1206CreonPancrelipase
    17856-1212CreonPancrelipase
    17856-1224CreonPancrelipase
    58914-112ViokacePancrelipase
    58914-117ViokacePancrelipase
    42865-300ZENPEPpancrelipase
    42865-302ZENPEPpancrelipase
    42865-303ZENPEPpancrelipase
    42865-304ZENPEPpancrelipase
    42865-305ZENPEPpancrelipase
    42865-306ZENPEPpancrelipase
    42865-307ZENPEPpancrelipase

    Trademark Results [PANCREAZE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PANCREAZE
    PANCREAZE
    77817201 3887562 Live/Registered
    VIVUS, INC.
    2009-09-01
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