1. Home
  2. Labeler Index
  3. Horizon Therapeutics Usa, Inc.
  4. 75987-050
  5. NDC Package Code: 75987-050-07 Ravicti

NDC Package 75987-050-07 Ravicti

Glycerol Phenylbutyrate Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
75987-050-07
Package Description:
4 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE
Product Code:
75987-050
Proprietary Name:
Ravicti
Non-Proprietary Name:
Glycerol Phenylbutyrate
Substance Name:
Glycerol Phenylbutyrate
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.
11-Digit NDC Billing Format:
75987005007
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Horizon Therapeutics Usa, Inc.
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
GLYCEROL PHENYLBUTYRATE 1.1 g/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA203284
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
02-28-2013
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
75987-050-061 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 75987-050-07?

The NDC Packaged Code 75987-050-07 is assigned to a package of 4 bottle in 1 carton / 25 ml in 1 bottle of Ravicti, a human prescription drug labeled by Horizon Therapeutics Usa, Inc.. The product's dosage form is liquid and is administered via oral form.

Is NDC 75987-050 included in the NDC Directory?

Yes, Ravicti with product code 75987-050 is active and included in the NDC Directory. The product was first marketed by Horizon Therapeutics Usa, Inc. on February 28, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 75987-050-07?

The 11-digit format is 75987005007. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-275987-050-075-4-275987-0050-07