Vancomycin Hydrochloride Solution
NDC Package 69238-2261-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Vancomycin Hydrochloride solution is vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. This formulation utilizes a solution delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2261 and is authorized under FDA application ANDA215338.

Identification & Billing

NDC Package Code
69238-2261-3
Package Description
80 mL in 1 BOTTLE
Product Code
69238-2261
11-Digit Billing Format
69238226103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
80 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vancomycin Hydrochloride
Non-Proprietary Name
Vancomycin Hydrochloride
Substance Name
Vancomycin Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VANCOMYCIN HYDROCHLORIDE 250 mg/5mL
Pharmacologic Class
Usage Information
Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications;therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215338
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2023
Listing Expiration
12-31-2027
Exclude Flag
N
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 (69238-2261). Click a package code to view its specific billing and regulatory data.

69238-2261-5
300 mL in 1 BOTTLE
69238-2261-7
150 mL in 1 BOTTLE

* 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 69238-2261-3 identifies a specific commercial package of 80 ml in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This solution is formulated for oral use and contains vancomycin hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Ny Llc on June 26, 2023. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238226103. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 80 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)
69238-2261-3
11-Digit CMS (5-4-2)
69238-2261-03

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