NDC 0032-1203 Creon

Pancrelipase Capsule, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0032-1203
Proprietary Name:
Creon
Non-Proprietary Name: [1]
Pancrelipase
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]
    Abbvie Inc.
    Labeler Code:
    0032
    FDA Application Number: [6]
    BLA020725
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-30-2009
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - BLUE OPAQUE BODY)
    ORANGE (C48331 - ORANGE OPAQUE CAP)
    BROWN (C48332 - COLORLESS TRANSPARENT BODY AND BROWN OPAQUE CAP)
    ORANGE (C48331 - COLORLESS TRANSPARENT BODY AND ORANGE OPAQUE CAP)
    WHITE (C48325 - WHITE OPAQUE BODY AND WHITE OPAQUE CAP)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    18 MM
    22 MM
    Imprint(s):
    CREON;1206
    CREON;1212
    CREON;1224
    CREON;1203
    Score:
    1

    Product Packages

    NDC Code 0032-1203-64

    Package Description: 1 BOTTLE in 1 CARTON / 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    NDC Code 0032-1203-70

    Package Description: 1 BOTTLE in 1 CARTON / 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    Price per Unit: $1.67339 per EA

    Product Details

    What is NDC 0032-1203?

    The NDC code 0032-1203 is assigned by the FDA to the product Creon which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Creon is pancrelipase. 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 0032-1203-64 1 bottle in 1 carton / 70 capsule, delayed release in 1 bottle, 0032-1203-70 1 bottle in 1 carton / 70 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 Creon?

    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 Creon 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.

    Which are Creon UNII Codes?

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

    Which are Creon Inactive Ingredients 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 Creon?

    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: 1113042 - lipase 3000 UNT / amylase 15,000 UNT / protease 9500 UNT Delayed Release Oral Capsule
    • RxCUI: 1113042 - amylase 15000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral Capsule
    • RxCUI: 1113042 - amylase 15,000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral Capsule
    • RxCUI: 1113042 - amylases 15,000 UNT / endopeptidases 9500 UNT / lipase 3000 UNT Delayed Release Oral Capsule
    • RxCUI: 1113046 - CREON 3000 UNT / 15,000 UNT / 9500 UNT Delayed Release Oral Capsule

    * Please review the disclaimer below.

    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 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".