NDC Package 71770-200-10 Pheburane

Sodium Phenylbutyrate Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

71770-200-10

Package Description:

1 KIT in 1 CARTON * 174 g in 1 BOTTLE (71770-210-10)

Product Code:

71770-200

Proprietary Name:

Pheburane

Non-Proprietary Name:

Sodium 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. Seek immediate medical attention 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:

71770020010

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

RxCUI: 2610128 - sodium phenylbutyrate 483 MG/GM Oral Pellet

RxCUI: 2610128 - sodium phenylbutyrate 0.483 MG/MG Oral Pellet

RxCUI: 2610134 - Pheburane 483 MG/GM Oral Pellet

RxCUI: 2610134 - sodium phenylbutyrate 0.483 MG/MG Oral Pellet [Pheburane]

RxCUI: 2610134 - Pheburane 0.483 MG/MG Oral Pellet

Product Type:

Human Prescription Drug

Labeler Name:

Medunik Usa

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

NDA216513

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

08-26-2022

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

71770 - Medunik Usa
- 71770-200 - Pheburane
  - 71770-200-10 - 1 KIT in 1 CARTON * 174 g in 1 BOTTLE (71770-210-10)

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.

Frequently Asked Questions

What is NDC 71770-200-10?

The NDC Packaged Code 71770-200-10 is assigned to a package of 1 kit in 1 carton * 174 g in 1 bottle (71770-210-10) of Pheburane, a human prescription drug labeled by Medunik Usa. The product's dosage form is kit and is administered via form.

Is NDC 71770-200 included in the NDC Directory?

Yes, Pheburane with product code 71770-200 is active and included in the NDC Directory. The product was first marketed by Medunik Usa on August 26, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 71770-200-10?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight.

What is the 11-digit format for NDC 71770-200-10?

The 11-digit format is 71770020010. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	71770-200-10	5-4-2	71770-0200-10

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