Ravicti
NDC Package 76325-100-25

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

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

Ravicti is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). Marketed by Hyperion Therapeutics, Inc., this product is identified by NDC 76325-100 and is authorized under FDA application NDA203284.

Identification & Billing

NDC Package Code
76325-100-25
Package Description
1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE
Product Code
76325-100
11-Digit Billing Format
76325010025
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Ravicti
Dosage Form
-
Usage Information
This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). It helps remove a certain chemical (ammonia) from the body. Too much ammonia in the body can cause brain damage and sometimes death. This medication should not be used to treat sudden, severely high levels of ammonia in the body. Get medical help right away if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

Regulatory & Marketing

Labeler Name
Hyperion Therapeutics, Inc.
FDA Application #
NDA203284
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-28-2013
End Marketing Date
07-31-2017
Listing Expiration
07-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76325-100). Click a package code to view its specific billing and regulatory data.

76325-100-04
4 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE

* 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 76325-100-25 identifies a specific commercial package of 1 bottle in 1 carton / 25 ml in 1 bottle of Ravicti, labeled by Hyperion Therapeutics, 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 Hyperion Therapeutics, Inc. on February 28, 2013. The current certification is valid through July 31, 2017.

What are the primary indications for this medication?

This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). It helps remove a certain chemical (ammonia) from the body. Too much ammonia in the body can cause brain damage and sometimes death. This medication should not be used to treat sudden, severely high levels of ammonia in the body. Get medical help right away if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

How is this Hyperion Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76325010025. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
76325-100-25
11-Digit CMS (5-4-2)
76325-0100-25

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