Pertzye Capsule, Delayed Release
NDC Package 59767-024-01

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

Package Information

Pertzye (pancrelipase) capsules is this medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. This formulation utilizes a capsule, delayed release delivery system. Marketed by Digestive Care, Inc., this product is identified by NDC 59767-024 and is authorized under FDA application BLA022175.

Identification & Billing

NDC Package Code
59767-024-01
Package Description
80 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
59767-024
11-Digit Billing Format
59767002401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
80 EA
RxNorm Crosswalk
  • RxCUI: 1294122 - lipase 16,000 UNT / amylase 60,500 UNT / protease 57,500 UNT Delayed Release Oral Capsule
  • RxCUI: 1294122 - amylase 60500 UNT / lipase 16000 UNT / protease 57500 UNT Delayed Release Oral Capsule
  • RxCUI: 1294122 - amylase 60,500 UNT / lipase 16,000 UNT / protease 57,500 UNT Delayed Release Oral Capsule
  • RxCUI: 1294122 - amylases 60,500 UNT / endopeptidases 57,500 UNT / lipase 16,000 UNT Delayed Release Oral Capsule
  • RxCUI: 1294128 - Pertzye 16,000 UNT / 60,500 UNT / 57,500 UNT Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Pertzye
Non-Proprietary Name
Pancrelipase
Substance Name
Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
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).

Regulatory & Marketing

Labeler Name
Digestive Care, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA022175
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-13-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59767-024). Click a package code to view its specific billing and regulatory data.

59767-024-00
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE
59767-024-02
200 CAPSULE, DELAYED RELEASE in 1 BOTTLE
59767-024-99
80 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* 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 59767-024-01 identifies a specific commercial package of 80 capsule, delayed release in 1 bottle of Pertzye, a human prescription drug labeled by Digestive Care, Inc.. This capsule, delayed release is formulated for oral 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 Digestive Care, Inc. on July 13, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Digestive Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59767002401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 80 total billable units per package. 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 (5-3-2)
59767-024-01
11-Digit CMS (5-4-2)
59767-0024-01

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