Ipratropium Bromide
NDC Package 54868-4082-0

11-digit billing NDC: 54868408200 · Billing unit: ML · 150 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ipratropium Bromide is inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4082 and is authorized under FDA application ANDA074755.

Identification & Billing

NDC Package Code
54868-4082-0
Package Description
12 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
Product Code
54868-4082
11-Digit Billing Format
54868408200
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
150 ML
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

Clinical Specifications

Proprietary Name
Ipratropium Bromide
Dosage Form
-
Usage Information
Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA074755
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-1998
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4082). Click a package code to view its specific billing and regulatory data.

54868-4082-1
5 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-4082-0 identifies a specific commercial package of 12 pouch in 1 carton / 5 vial in 1 pouch / 2.5 ml in 1 vial of Ipratropium Bromide, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 150 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on December 03, 1998. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868408200. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 150 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54868-4082-0
11-Digit CMS (5-4-2)
54868-4082-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.