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  5. NDC Package Code: 0378-9040-05 Cystagon

NDC Package 0378-9040-05 Cystagon

Cysteamine Bitartrate Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0378-9040-05
Package Description:
500 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
0378-9040
Proprietary Name:
Cystagon
Non-Proprietary Name:
Cysteamine Bitartrate
Substance Name:
Cysteamine Bitartrate
Usage Information:
This medication is used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis). Cystine build-up can cause problems such as kidney problems, slow growth, weak bones, and eye problems. Cysteamine helps the body get rid of cystine.
11-Digit NDC Billing Format:
00378904005
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 209788 - Cystagon 150 MG Oral Capsule
  • RxCUI: 209788 - cysteamine 150 MG Oral Capsule [Cystagon]
  • RxCUI: 209789 - Cystagon 50 MG Oral Capsule
  • RxCUI: 209789 - cysteamine 50 MG Oral Capsule [Cystagon]
  • RxCUI: 309636 - cysteamine bitartrate 150 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CYSTEAMINE BITARTRATE 50 mg/1
    • Pharmacologic Class(es):
  • Cystine Depleting Agent - [EPC] (Established Pharmacologic Class)
  • Cystine Disulfide Reduction - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA020392
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-11-2005
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 0378-9040-05?

    The NDC Packaged Code 0378-9040-05 is assigned to a package of 500 capsule in 1 bottle, plastic of Cystagon, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package.

    Is NDC 0378-9040 included in the NDC Directory?

    Yes, Cystagon with product code 0378-9040 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on April 11, 2005 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 0378-9040-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 0378-9040-05?

    The 11-digit format is 00378904005. 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 4-4-2 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
    4-4-20378-9040-055-4-200378-9040-05