NDC Package 69238-2261-3 Vancomycin Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
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:

69238-2261-3

Package Description:

80 mL in 1 BOTTLE

Product Code:

69238-2261

Proprietary Name:

Vancomycin Hydrochloride

Non-Proprietary Name:

Vancomycin Hydrochloride

Substance Name:

Vancomycin Hydrochloride

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.

11-Digit NDC Billing Format:

69238226103

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

80 ML

NDC to RxNorm Crosswalk:

RxCUI: 2000134 - vancomycin 50 MG/mL Oral Solution

RxCUI: 2000134 - vancomycin 50 MG/ML Oral Solution

RxCUI: 2000134 - vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution

RxCUI: 2000134 - vancomycin 15 GM per 289 ML Powder for Oral Solution

RxCUI: 2000134 - vancomycin 250 MG per 5 ML Powder for Oral Solution

Product Type:

Human Prescription Drug

Labeler Name:

Amneal Pharmaceuticals Ny Llc

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):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

VANCOMYCIN HYDROCHLORIDE 250 mg/5mL

Pharmacologic Class(es):

Glycopeptide Antibacterial - [EPC] (Established Pharmacologic Class)

Glycopeptides - [CS]

Sample Package:

FDA Application Number:

ANDA215338

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-26-2023

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

69238 - Amneal Pharmaceuticals Ny Llc
- 69238-2261 - Vancomycin Hydrochloride
  - 69238-2261-3 - 80 mL in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
69238-2261-5	300 mL in 1 BOTTLE
69238-2261-7	150 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 69238-2261-3?

The NDC Packaged Code 69238-2261-3 is assigned to a package of 80 ml in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is solution and is administered via oral form.

Is NDC 69238-2261 included in the NDC Directory?

Yes, Vancomycin Hydrochloride with product code 69238-2261 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on June 26, 2023 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 69238-2261-3?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 80.

What is the 11-digit format for NDC 69238-2261-3?

The 11-digit format is 69238226103. 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 5-4-1 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	69238-2261-3	5-4-2	69238-2261-03

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