Trulance
NDC Package 70194-003-30

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Trulance is see also Warning section. Marketed by Synergy Pharmaceuticals Inc., this product is identified by NDC 70194-003 and is authorized under FDA application NDA208745.

Identification & Billing

NDC Package Code
70194-003-30
Package Description
1 BLISTER PACK in 1 CARTON / 30 TABLET in 1 BLISTER PACK
Product Code
70194-003
11-Digit Billing Format
70194000330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Trulance Immediate Release
Dosage Form
-
Usage Information
See also Warning section. Plecanatide is used to treat certain types of bowel problems (chronic idiopathic constipation, irritable bowel syndrome with constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Plecanatide may improve stool texture and lessen symptoms such as straining and feelings of incomplete bowel movements. This medication must not be used in children younger than 6 years because of the risk of serious side effects.

Regulatory & Marketing

Labeler Name
Synergy Pharmaceuticals Inc.
FDA Application #
NDA208745
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-21-2017
End Marketing Date
12-31-2020
Listing Expiration
12-31-2020
Exclude Flag
D
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 70194-003-30 identifies a specific commercial package of 1 blister pack in 1 carton / 30 tablet in 1 blister pack of Trulance Immediate Release, labeled by Synergy Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Synergy Pharmaceuticals Inc. on February 21, 2017. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

See also Warning section. Plecanatide is used to treat certain types of bowel problems (chronic idiopathic constipation, irritable bowel syndrome with constipation). It works by increasing fluid in your intestines and helping speed up movement of food through the gut. Plecanatide may improve stool texture and lessen symptoms such as straining and feelings of incomplete bowel movements. This medication must not be used in children younger than 6 years because of the risk of serious side effects.

How is this Synergy Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70194000330. 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)
70194-003-30
11-Digit CMS (5-4-2)
70194-0003-30

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