Symproic Tablet
NDC Package 59385-041-07

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

Symproic (naldemedine) tablets is a medication used to treat constipation caused by opioid medication. This formulation utilizes a tablet delivery system. Marketed by Biodelivery Sciences International Inc, this product is identified by NDC 59385-041 and is authorized under FDA application NDA208854.

Identification & Billing

NDC Package Code
59385-041-07
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
Product Code
59385-041
11-Digit Billing Format
59385004107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Symproic
Non-Proprietary Name
Naldemedine
Substance Name
Naldemedine Tosylate
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)
NALDEMEDINE TOSYLATE .2 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Naldemedine belongs to a class of medications known as opioid antagonists.

Regulatory & Marketing

Labeler Name
Biodelivery Sciences International Inc
Product Type
Human Prescription Drug
FDA Application #
NDA208854
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-14-2019
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 (59385-041). Click a package code to view its specific billing and regulatory data.

59385-041-30
30 TABLET in 1 BOTTLE, PLASTIC

* 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 59385-041-07 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet in 1 blister pack of Symproic, a human prescription drug labeled by Biodelivery Sciences International Inc. This tablet is formulated for oral use and contains naldemedine tosylate 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 Biodelivery Sciences International Inc on June 14, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Naldemedine belongs to a class of medications known as opioid antagonists.

How is this Biodelivery Sciences International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59385004107. 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)
59385-041-07
11-Digit CMS (5-4-2)
59385-0041-07

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