Pancrelipase Capsule, Delayed Release Pellets
NDC Package 54809-1024-8

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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 capsules is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Abbott Laboratories Gmbh, this product is identified by NDC 54809-1024.

Identification & Billing

NDC Package Code
54809-1024-8
Package Description
80000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM
Product Code
54809-1024
11-Digit Billing Format
54809102408

Clinical Specifications

Proprietary Name
Pancrelipase
Non-Proprietary Name
Pancrelipase
Substance Name
Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease
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.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Abbott Laboratories Gmbh
Product Type
Bulk Ingredient
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
10-21-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54809-1024-8 identifies a specific commercial package of 80000 capsule, delayed release pellets in 1 drum of Pancrelipase (UNFINISHED drug), a bulk ingredient labeled by Abbott Laboratories Gmbh. This capsule, delayed release pellets is formulated for use and contains pancrelipase amylase; pancrelipase lipase; pancrelipase protease as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Abbott Laboratories Gmbh on October 21, 2013. The current certification is valid through December 31, 2027.

How is this Abbott Laboratories Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54809102408. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54809-1024-8
11-Digit CMS (5-4-2)
54809-1024-08

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.