NDC Package 0378-7970-93 Ipratropium Bromide

Solution Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

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:
0378-7970-93
Package Description:
1 POUCH in 1 CARTON / 30 AMPULE in 1 POUCH (0378-7970-64) / 2.5 mL in 1 AMPULE
Product Code:
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:
00378797093
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 836358 - ipratropium bromide 0.02 % Inhalation Solution
  • RxCUI: 836358 - ipratropium bromide 0.2 MG/ML Inhalation Solution
  • RxCUI: 836358 - ipratropium bromide 0.5 MG per 2.5 ML Inhalation Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA075693
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-09-2010
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0378-7970-93 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00378797093J7644Ipratropium bromide non-comp1 MG2.5300.515

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    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0378-7970-521 POUCH in 1 CARTON / 25 AMPULE in 1 POUCH (0378-7970-62) / 2.5 mL in 1 AMPULE
    0378-7970-5530 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (0378-7970-31) / 2.5 mL in 1 AMPULE
    0378-7970-912 POUCH in 1 CARTON / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-7970-93?

    The NDC Packaged Code 0378-7970-93 is assigned to a package of 1 pouch in 1 carton / 30 ampule in 1 pouch (0378-7970-64) / 2.5 ml in 1 ampule of Ipratropium Bromide, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is solution and is administered via respiratory (inhalation) form.

    Is NDC 0378-7970 included in the NDC Directory?

    Yes, Ipratropium Bromide with product code 0378-7970 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on November 09, 2010 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 0378-7970-93?

    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 0378-7970-93?

    The 11-digit format is 00378797093. 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
    4-4-20378-7970-935-4-200378-7970-93