NDC 0023-6113

Zenpep

Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase

Zenpep is a Oral Capsule, Delayed Release 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 ID0023-6113_6b416bc9-3782-4f76-94a2-753d51f34202
NDC0023-6113
Product TypeHuman Prescription Drug
Proprietary NameZenpep
Generic NamePancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-10-31
Marketing CategoryNDA / NDA
Application NumberNDA022210
Labeler NameAllergan, Inc.
Substance NamePANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active Ingredient Strength3000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0023-6113-01

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (0023-6113-01)
Marketing Start Date2017-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-6113-01 [00023611301]

Zenpep CAPSULE, DELAYED RELEASE
Marketing CategoryBLA
Application NumberBLA022210
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-31

Drug Details

Active Ingredients

IngredientStrength
PANCRELIPASE LIPASE3000 [USP'U]/1

OpenFDA Data

SPL SET ID:f439e3a8-d60e-45f2-899c-d9be9b048b2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1995479
  • 1595292
  • 1595478
  • 1595290
  • 1594673
  • 1995477
  • 1594671
  • 1595455
  • 1595457
  • 1595473
  • 1595471
  • 1595476
  • 1595460
  • 1595462
  • NDC Crossover Matching brand name "Zenpep" or generic name "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"

    NDCBrand NameGeneric Name
    0023-6110ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6111ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6112ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6113ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6114ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6115ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    0023-6116ZenpepPANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
    42865-300ZENPEPpancrelipase
    42865-302ZENPEPpancrelipase
    42865-303ZENPEPpancrelipase
    42865-304ZENPEPpancrelipase
    42865-305ZENPEPpancrelipase
    42865-306ZENPEPpancrelipase
    42865-307ZENPEPpancrelipase
    73562-110Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-111Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-112Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-113Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-114Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-115Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase
    73562-116Zenpeppancrelipase lipase, pancrelipase protease, pancrelipase amylase

    Trademark Results [Zenpep]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZENPEP
    ZENPEP
    77514395 3747475 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
    2008-07-03

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.