Zenpep
NDC 42865-304
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Zenpep is a NDA-approved product labeled by Allergan, Inc.. This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is supplied as a product. This product entry covers the primary NDC 42865-304 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
42865-304
Proprietary Name:
Zenpep
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
42865
FDA Application Number: [6]
NDA022210
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
09-22-2009
End Marketing Date: [10]
08-31-2020
Listing Expiration Date: [11]
08-31-2020
Exclude Flag: [12]
D
Code Structure Chart
Patient Education
Pancrelipase
Pancrelipase delayed-release capsules (Creon, Pancreaze, Pertzye, Ultresa, Zenpep) are used to improve digestion of food in children and adults who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food) such as cystic fibrosis (an inborn disease that causes the body to produce thick, sticky mucus that may clog the pancreas, the lungs, and other parts of the body), chronic pancreatitis (swelling of the pancreas that does not go away), or a blockage in the passages between the pancreas and the intestine. Pancrelipase delayed-release capsules (Creon, Pancreaze, Zenpep) are also used to improve digestion of food in infants who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have cystic fibrosis or another condition that affects the pancreas. Pancrelipase delayed-release capsules (Creon) are also used to improve digestion in people who have had surgery to remove all or part of the pancreas or stomach. Pancrelipase tablets (Viokace) are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who have chronic pancreatitis or who have had surgery to remove the pancreas. Pancrelipase is in a class of medications called enzymes. Pancrelipase acts in place of the enzymes normally made by the pancreas. It works to decrease fatty bowel movements and to improve nutrition by breaking down fats, proteins, and starches from food into smaller substances that can be absorbed from the intestine.
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Lipase
What is it? Lipase is an enzyme that breaks down fats during digestion. It is found in many plants, animals, bacteria, and molds. Some people use lipase as a medicine.
Since lipase breaks down fat into smaller pieces, it is possible that lipase supplements might make digestion easier.
Lipase is used for indigestion (dyspepsia), heartburn, and other gastrointestinal problems, but there is no good scientific evidence to support these uses.
Do not confuse lipase with pancreatic enzyme products. Pancreatic enzyme products contain multiple ingredients, including lipase. Some of these products are approved by the US FDA for digestion problems due to a disorder of the pancreas (pancreatic insufficiency).
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
