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  5. NDC Package Code: 0054-0334-25 Cevimeline Hydrochloride

NDC Package 0054-0334-25 Cevimeline Hydrochloride

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:
0054-0334-25
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
0054-0334
Proprietary Name:
Cevimeline Hydrochloride
Non-Proprietary Name:
Cevimeline Hydrochloride
Substance Name:
Cevimeline Hydrochloride
Usage Information:
Cevimeline hydrochloride is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
11-Digit NDC Billing Format:
00054033425
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 309140 - cevimeline HCl 30 MG Oral Capsule
  • RxCUI: 309140 - cevimeline hydrochloride 30 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa 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):
  • CEVIMELINE HYDROCHLORIDE 30 mg/1
    • Pharmacologic Class(es):
  • Cholinergic Muscarinic Agonists - [MoA] (Mechanism of Action)
  • Cholinergic Receptor Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA091591
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-08-2013
    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 0054-0334-25?

    The NDC Packaged Code 0054-0334-25 is assigned to a package of 100 capsule in 1 bottle of Cevimeline Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0054-0334 included in the NDC Directory?

    Yes, Cevimeline Hydrochloride with product code 0054-0334 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on July 08, 2013 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 0054-0334-25?

    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 100.

    What is the 11-digit format for NDC 0054-0334-25?

    The 11-digit format is 00054033425. 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
    4-4-20054-0334-255-4-200054-0334-25