Viokace Tablet
NDC Package 73562-104-10

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

Package Information

Viokace (pancrelipase) tablets is a medication used along with a proton pump inhibitor medicine to treat people who cannot digest food normally. This formulation utilizes a tablet delivery system. Marketed by Aimmune Therapeutics, Inc., this product is identified by NDC 73562-104 and is authorized under FDA application BLA022542.

Identification & Billing

NDC Package Code
73562-104-10
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
73562-104
11-Digit Billing Format
73562010410
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: 1247379 - lipase 20,880 UNT / amylase 78,300 UNT / protease 78,300 UNT Oral Tablet
  • RxCUI: 1247379 - amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet
  • RxCUI: 1247379 - amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT Oral Tablet
  • RxCUI: 1247379 - amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet
  • RxCUI: 1247381 - Viokace 20,880 UNT / 78,300 UNT / 78,300 UNT Oral Tablet

Clinical Specifications

Proprietary Name
Viokace
Non-Proprietary Name
Pancrelipase
Substance Name
Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
This medication is used along with a proton pump inhibitor medicine to treat people who cannot digest food normally. The pancreas is an organ in your body that normally produces enzymes to help you digest food. Certain conditions, such as surgical removal of some or all of the pancreas, or chronic pancreatitis, can decrease the production or release of these enzymes into the bowel (intestine). Pancrelipase contains a mixture of digestive enzymes (from pig pancreas) to help breakdown and digest fats, starches, and proteins in food.

Regulatory & Marketing

Labeler Name
Aimmune Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA022542
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2021
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 73562-104-10 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Viokace, a human prescription drug labeled by Aimmune Therapeutics, Inc.. This tablet 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 Aimmune Therapeutics, Inc. on March 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with a proton pump inhibitor medicine to treat people who cannot digest food normally. The pancreas is an organ in your body that normally produces enzymes to help you digest food. Certain conditions, such as surgical removal of some or all of the pancreas, or chronic pancreatitis, can decrease the production or release of these enzymes into the bowel (intestine). Pancrelipase contains a mixture of digestive enzymes (from pig pancreas) to help breakdown and digest fats, starches, and proteins in food.

How is this Aimmune Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73562010410. 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)
73562-104-10
11-Digit CMS (5-4-2)
73562-0104-10

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