1. Home
  2. Labeler Index
  3. Aimmune Therapeutics, Inc.
  4. NDC Product Code: 73562-117 Zenpep

NDC 73562-117 Zenpep

Pancrelipase Lipase,Pancrelipase Protease,Pancrelipase Amylase Capsule, Delayed Release - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 73562-117?
  4. Zenpep Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
73562-117
Proprietary Name:
Zenpep
Non-Proprietary Name: [1]
Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase
Substance Name: [2]
Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Aimmune Therapeutics, Inc.
    Labeler Code:
    73562
    Product Label ID:
    7f16f2d4-8df6-4bd7-ac10-56994fa257b0
    FDA Application Number: [6]
    BLA022210
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    11-01-2020
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 73562-117?

    The NDC code 73562-117 is assigned by the FDA to the product Zenpep which is a human prescription drug product labeled by Aimmune Therapeutics, Inc.. The generic name of Zenpep is pancrelipase lipase, pancrelipase protease, pancrelipase amylase. The product's dosage form is capsule, delayed release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 73562-117-01 100 capsule, delayed release in 1 bottle , 73562-117-12 12 capsule, delayed release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Zenpep?

    This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (conditions such as chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

    What are Zenpep Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    What is the NDC to RxNorm Crosswalk for Zenpep?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1594671 - lipase 25,000 UNT / amylase 105,000 UNT / protease 79,000 UNT Delayed Release Oral Capsule
    • RxCUI: 1594671 - amylase 105000 UNT / lipase 25000 UNT / protease 79000 UNT Delayed Release Oral Capsule
    • RxCUI: 1594671 - amylase 105,000 UNT / lipase 25,000 UNT / protease 79,000 UNT Delayed Release Oral Capsule
    • RxCUI: 1594671 - amylases 105,000 UNT / endopeptidases 79,000 UNT / lipase 25,000 UNT Delayed Release Oral Capsule
    • RxCUI: 1594673 - Zenpep 25,000 UNT / 105,000 UNT / 79,000 UNT Delayed Release Oral Capsule

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".