Pancreaze Capsule, Delayed Release
NDC Package 62541-404-10

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

Package Information

Pancreaze (pancrelipase lipase, pancrelipase amylase, and pancrelipase protease) 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 Vivus Llc, this product is identified by NDC 62541-404 and is authorized under FDA application BLA022523.

Identification & Billing

NDC Package Code
62541-404-10
Package Description
1 BOTTLE, GLASS in 1 CARTON / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS
Product Code
62541-404
11-Digit Billing Format
62541040410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Pancreaze
Non-Proprietary Name
Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease
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
Vivus Llc
Product Type
Human Prescription Drug
FDA Application #
BLA022523
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-12-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62541-404-10 identifies a specific commercial package of 1 bottle, glass in 1 carton / 100 capsule, delayed release in 1 bottle, glass of Pancreaze, a human prescription drug labeled by Vivus Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Vivus Llc on April 12, 2010. 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 Vivus Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62541040410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
62541-404-10
11-Digit CMS (5-4-2)
62541-0404-10

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