Pancrelipase Capsule, Delayed Release Pellets
NDC 54809-9048

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54809-9048?
  5. Active Ingredients
  6. Active Ingredients UNII Codes

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pancrelipase is a EXPORT ONLY-approved product labeled by Abbott Laboratories Gmbh. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a orange capsule, delayed release pellets. This product entry covers the primary NDC 54809-9048 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54809-9048
Proprietary Name:
Pancrelipase
Non-Proprietary Name: [1]
Pancrelipase
Substance Name: [2]
Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.

Labeler & Regulatory Data

Labeler Name: [5]
Abbott Laboratories Gmbh
Labeler Code:
54809
Product Label ID:
c29a4461-377f-402f-9f86-7b03f1be2aa4
Marketing Category: [8]
EXPORT ONLY - A product that is only exported and not marketed in the United States.

Marketing Timeline

Start Marketing Date: [9]
10-21-2013
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes

Product Characteristics

Color(s):
ORANGE (C48331)
WHITE (C48325 - OPAQUE)
BLUE (C48333)
BROWN (C48332)
BLUE (C48333 - OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
14 MM
18 MM
25 MM
Imprint(s):
CREON;1224
CREON;1203
CREON;1206
CREON;1212
CREON;1236
Score:
1

Code Structure Chart

Product Details

What is NDC 54809-9048?

The NDC code 54809-9048 is assigned by the FDA to the product Pancrelipase. It is commonly known by its generic name, pancrelipase. This pharmaceutical product is labeled by Abbott Laboratories Gmbh and is currently categorized as listed product. The medication is a capsule, delayed release pellets. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54809-9048-8. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

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:

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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 is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.