1. Home
  2. Labeler Index
  3. Hikma Pharmaceuticals Usa Inc.
  4. 0054-0046
  5. NDC Package Code: 0054-0046-41 Ipratropium Bromide

NDC Package 0054-0046-41 Ipratropium Bromide

Spray Nasal - 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:
0054-0046-41
Package Description:
1 BOTTLE, SPRAY in 1 CARTON / 165 SPRAY in 1 BOTTLE, SPRAY
Product Code:
0054-0046
Proprietary Name:
Ipratropium Bromide
Non-Proprietary Name:
Ipratropium Bromide
Substance Name:
Ipratropium Bromide
Usage Information:
Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. For preventing symptoms of lung disease, this medication must be used regularly to be effective. Use your quick-relief inhaler or nebulized solution (such as albuterol, also called salbutamol in some countries) for wheezing or sudden shortness of breath unless otherwise directed by your doctor. Ipratropium does not work as fast as your quick-relief medication, but may sometimes be used together with your quick-relief medication to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.
11-Digit NDC Billing Format:
00054004641
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1797844 - ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal Spray
  • RxCUI: 1797844 - ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797844 - ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal Spray
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • IPRATROPIUM BROMIDE 42 ug/1
    • Pharmacologic Class(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076598
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-05-2003
    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.

    Frequently Asked Questions

    What is NDC 0054-0046-41?

    The NDC Packaged Code 0054-0046-41 is assigned to a package of 1 bottle, spray in 1 carton / 165 spray in 1 bottle, spray of Ipratropium Bromide, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is spray and is administered via nasal form.

    Is NDC 0054-0046 included in the NDC Directory?

    Yes, Ipratropium Bromide with product code 0054-0046 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on November 05, 2003 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 NDC billing unit for package 0054-0046-41?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0054-0046-41?

    The 11-digit format is 00054004641. 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
    4-4-20054-0046-415-4-200054-0046-41