NDC 62541-405

PANCREAZE

Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease

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

Product ID62541-405_7ad0b87a-b79f-9800-e053-2991aa0a7bdc
NDC62541-405
Product TypeHuman Prescription Drug
Proprietary NamePANCREAZE
Generic NamePancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-04-12
Marketing CategoryNDA / NDA
Application NumberNDA022523
Labeler NameVIVUS, Inc.
Substance NamePANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
Active Ingredient Strength21000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62541-405-10

1 BOTTLE, GLASS in 1 CARTON (62541-405-10) > 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 62541-405-10 [62541040510]

PANCREAZE CAPSULE, DELAYED RELEASE
Marketing CategoryBLA
Application NumberBLA022523
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-12

Drug Details

Active Ingredients

IngredientStrength
PANCRELIPASE LIPASE21000 [USP'U]/1

OpenFDA Data

SPL SET ID:e8f5d2fe-728d-42af-99a6-83dddc6539c5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806926
  • 1806924
  • 1806931
  • 1806921
  • 1806919
  • 1806966
  • 1806929
  • 1806964
  • 1806953
  • 1806955
  • NDC Crossover Matching brand name "PANCREAZE" or generic name "Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease"

    NDCBrand NameGeneric Name
    50458-341PANCREAZEPANCRELIPASE
    50458-342PANCREAZEPANCRELIPASE
    50458-343PANCREAZEPANCRELIPASE
    50458-346PANCREAZEPANCRELIPASE
    50458-347PANCREAZEPANCRELIPASE
    62541-401PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
    62541-402PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
    62541-403PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
    62541-404PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
    62541-405PANCREAZEPANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE

    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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