Acetylcysteine
NDC Package 54868-5670-0

11-digit billing NDC: 54868567000 · Billing unit: ML · 30 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)Pulmonary complications of cystic fibrosisTracheostomy carePulmonary complications associated with surgeryUse during anesthesiaPost-traumatic chest conditionsAtelectasis due to mucous obstructionDiagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization) Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5670 and is authorized under FDA application ANDA072324.

Identification & Billing

NDC Package Code
54868-5670-0
Package Description
1 VIAL in 1 BOTTLE, DISPENSING / 30 mL in 1 VIAL
Product Code
54868-5670
11-Digit Billing Format
54868567000
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetylcysteine
Dosage Form
-
Usage Information
Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)Pulmonary complications of cystic fibrosisTracheostomy carePulmonary complications associated with surgeryUse during anesthesiaPost-traumatic chest conditionsAtelectasis due to mucous obstructionDiagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization) Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA072324
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5670-0 identifies a specific commercial package of 1 vial in 1 bottle, dispensing / 30 ml in 1 vial of Acetylcysteine, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 30 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 June 29, 2009. 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: 54868567000. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 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)
54868-5670-0
11-Digit CMS (5-4-2)
54868-5670-00

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