Zokinvy
NDC Package 73079-075-30

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 inactivated by the FDA.

Zokinvy is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulationHomozygous or compound heterozygous ZMPSTE24 mutations Limitations of UseZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Marketed by Eiger Biopharmaceuticals, Inc., this product is identified by NDC 73079-075 and is authorized under FDA application NDA213969.

Identification & Billing

NDC Package Code
73079-075-30
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
73079-075
11-Digit Billing Format
73079007530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zokinvy
Dosage Form
-
Usage Information
ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulationHomozygous or compound heterozygous ZMPSTE24 mutations Limitations of UseZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.

Regulatory & Marketing

Labeler Name
Eiger Biopharmaceuticals, Inc.
FDA Application #
NDA213969
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-20-2020
Listing Expiration
12-31-2025
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 73079-075-30 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 capsule in 1 bottle, plastic of Zokinvy, labeled by Eiger Biopharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Eiger Biopharmaceuticals, Inc. on November 20, 2020. The current certification is valid through December 31, 2025.

How is this Eiger Biopharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73079007530. 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)
73079-075-30
11-Digit CMS (5-4-2)
73079-0075-30

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