NDC 58914-117

Viokace

Pancrelipase

Viokace is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Pancrelipase Lipase; Pancrelipase Protease; Pancrelipase Amylase.

Product ID58914-117_02cbdbc3-7d70-4f5f-afa4-5d16a15852fb
NDC58914-117
Product TypeHuman Prescription Drug
Proprietary NameViokace
Generic NamePancrelipase
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-03-01
Marketing CategoryBLA / NDA
Application NumberBLA022542
Labeler NameAllergan, Inc.
Substance NamePANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active Ingredient Strength20880 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58914-117-10

1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE
Marketing Start Date2012-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58914-117-10 [58914011710]

Viokace TABLET
Marketing CategoryBLA
Application NumberBLA022542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-01

Drug Details

Active Ingredients

IngredientStrength
PANCRELIPASE LIPASE20880 [USP'U]/1

OpenFDA Data

SPL SET ID:d85c7e20-4e1d-43cd-a64b-ced3bda70eed
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1247388
  • 1247381
  • 1247386
  • 1247379
    • UPC Code
  • 0358914112105

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

    NDCBrand NameGeneric Name
    58914-112ViokacePancrelipase
    58914-117ViokacePancrelipase
    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
    42865-300ZENPEPpancrelipase
    42865-302ZENPEPpancrelipase
    42865-303ZENPEPpancrelipase
    42865-304ZENPEPpancrelipase
    42865-305ZENPEPpancrelipase
    42865-306ZENPEPpancrelipase
    42865-307ZENPEPpancrelipase

    Trademark Results [Viokace]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIOKACE
    VIOKACE
    77896647 4533794 Live/Registered
    ALLERGAN SALES, LLC
    2009-12-18
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.