Lyvispah
NDC Package 70257-412-87

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 inactivated by the FDA.

Lyvispah is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Limitations of UseLYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Marketed by Saol Therapeutics Inc, this product is identified by NDC 70257-412 and is authorized under FDA application NDA215422.

Identification & Billing

NDC Package Code
70257-412-87
Package Description
90 PACKET in 1 BOTTLE, UNIT-DOSE / 1 GRANULE in 1 PACKET
Product Code
70257-412
11-Digit Billing Format
70257041287
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lyvispah
Dosage Form
-
Usage Information
LYVISPAH is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Limitations of UseLYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Regulatory & Marketing

Labeler Name
Saol Therapeutics Inc
FDA Application #
NDA215422
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-22-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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 70257-412-87 identifies a specific commercial package of 90 packet in 1 bottle, unit-dose / 1 granule in 1 packet of Lyvispah, labeled by Saol Therapeutics Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. 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 Saol Therapeutics Inc on November 22, 2021. The current certification is valid through December 31, 2024.

How is this Saol Therapeutics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70257041287. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
70257-412-87
11-Digit CMS (5-4-2)
70257-0412-87

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