Prialt Injection, Solution
NDC Package 68118-723-10

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

Package Information

Prialt (ziconotide acetate) injection is a medication a non-opioid pain reliever that is used to treat ongoing pain when other treatments or medications cannot control your pain. This formulation utilizes a injection, solution delivery system. Marketed by Esteve Pharmaceuticals, S.a., this product is identified by NDC 68118-723 and is authorized under FDA application NDA021060.

Identification & Billing

NDC Package Code
68118-723-10
Package Description
1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS
Product Code
68118-723
11-Digit Billing Format
68118072310

Clinical Specifications

Proprietary Name
Prialt
Non-Proprietary Name
Ziconotide Acetate
Substance Name
Ziconotide Acetate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)
ZICONOTIDE ACETATE 500 ug/20mL
Pharmacologic Class
Usage Information
This medication is a non-opioid pain reliever that is used to treat ongoing pain when other treatments or medications cannot control your pain. Ziconotide works by blocking the nerves in the spinal cord that send pain signals. It decreases ongoing pain caused by cancer, AIDS, failed back surgery, multiple sclerosis, neuropathy, and other causes.

Regulatory & Marketing

Labeler Name
Esteve Pharmaceuticals, S.a.
Product Type
Human Prescription Drug
FDA Application #
NDA021060
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2018
Listing Expiration
12-31-2027
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 68118-723-10 identifies a specific commercial package of 1 vial, glass in 1 carton / 20 ml in 1 vial, glass of Prialt, a human prescription drug labeled by Esteve Pharmaceuticals, S.a.. This injection, solution is formulated for intrathecal use and contains ziconotide acetate 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 Esteve Pharmaceuticals, S.a. on October 15, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is a non-opioid pain reliever that is used to treat ongoing pain when other treatments or medications cannot control your pain. Ziconotide works by blocking the nerves in the spinal cord that send pain signals. It decreases ongoing pain caused by cancer, AIDS, failed back surgery, multiple sclerosis, neuropathy, and other causes.

How is this Esteve Pharmaceuticals, S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68118072310. 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)
68118-723-10
11-Digit CMS (5-4-2)
68118-0723-10

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