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  5. NDC Package Code: 66215-201-90 Zavesca

NDC Package 66215-201-90 Zavesca

Miglustat 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:
66215-201-90
Package Description:
6 BLISTER PACK in 1 CARTON / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)
Product Code:
66215-201
Proprietary Name:
Zavesca
Non-Proprietary Name:
Miglustat
Substance Name:
Miglustat
Usage Information:
Miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). It works by decreasing the amount of a certain natural fatty substance (glucosylceramide) that builds up due to this condition. This can help improve symptoms of Gaucher's disease, such as tiredness, pain in the joints/bones, and a swollen liver or spleen.
11-Digit NDC Billing Format:
66215020190
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
6 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 401938 - migLUstat 100 MG Oral Capsule
  • RxCUI: 401938 - miglustat 100 MG Oral Capsule
  • RxCUI: 541070 - Zavesca 100 MG Oral Capsule
  • RxCUI: 541070 - miglustat 100 MG Oral Capsule [Zavesca]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actelion Pharmaceuticals Us, 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):
  • MIGLUSTAT 100 mg/1
    • Pharmacologic Class(es):
  • Glucosylceramide Synthase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Glucosylceramide Synthase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021348
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-31-2003
    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 66215-201-90?

    The NDC Packaged Code 66215-201-90 is assigned to a package of 6 blister pack in 1 carton / 15 capsule in 1 blister pack (66215-201-15) of Zavesca, a human prescription drug labeled by Actelion Pharmaceuticals Us, 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 6 billable units per package.

    Is NDC 66215-201 included in the NDC Directory?

    Yes, Zavesca with product code 66215-201 is active and included in the NDC Directory. The product was first marketed by Actelion Pharmaceuticals Us, Inc. on July 31, 2003 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 66215-201-90?

    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 6.

    What is the 11-digit format for NDC 66215-201-90?

    The 11-digit format is 66215020190. 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
    5-3-266215-201-905-4-266215-0201-90