Pancreaze Capsule, Delayed Release
NDC 62541-402

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 62541-402?
  5. Pancreaze Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

Pancreaze (pancrelipase lipase, pancrelipase amylase, and pancrelipase protease) is a BLA-approved product labeled by Vivus Llc. This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is supplied as a yellow capsule, delayed release for oral administration. This product entry covers the primary NDC 62541-402 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
62541-402
Proprietary Name:
Pancreaze
Non-Proprietary Name: [1]
Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease
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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Vivus Llc
Labeler Code:
62541
Product Label ID:
e8f5d2fe-728d-42af-99a6-83dddc6539c5
FDA Application Number: [6]
BLA022523
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
04-12-2010
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
VIVUS;MT;4
Score:
1

Code Structure Chart

Product Details

What is NDC 62541-402?

The NDC code 62541-402 is assigned by the FDA to the product Pancreaze. It is commonly known by its generic name, pancrelipase lipase, pancrelipase amylase, and pancrelipase protease. This pharmaceutical product is labeled by Vivus Llc and is currently categorized as listed product. The medication is a capsule, delayed release administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 62541-402-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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: 1806919 - lipase 10,500 UNT / amylase 61,500 UNT / protease 35,500 UNT Delayed Release Oral Capsule
  • RxCUI: 1806919 - amylase 61500 UNT / lipase 10500 UNT / protease 35500 UNT Delayed Release Oral Capsule
  • RxCUI: 1806919 - amylase 61,500 UNT / lipase 10,500 UNT / protease 35,500 UNT Delayed Release Oral Capsule
  • RxCUI: 1806919 - amylases 61,500 UNT / endopeptidases 35,500 UNT / lipase 10,500 UNT Delayed Release Oral Capsule
  • RxCUI: 1806921 - PANCREAZE 10,500 UNT / 61,500 UNT / 35,500 UNT Delayed Release Oral Capsule

* Please review the full disclaimer at the bottom of this page.

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.
[Learn More]


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).


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 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".