Vancomycin Hydrochloride Kit
NDC Package 67877-751-58

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 kits is vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age.Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.Important Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.• Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.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. This formulation utilizes a kit delivery system. Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-751 and is authorized under FDA application ANDA214913.

Identification & Billing

NDC Package Code
67877-751-58
Package Description
1 KIT in 1 CARTON * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE
Product Code
67877-751
11-Digit Billing Format
67877075158
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vancomycin Hydrochloride
Non-Proprietary Name
Vancomycin Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age.Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.Important Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.• Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.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
Ascend Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214913
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2023
Listing Expiration
12-31-2026
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 (67877-751). Click a package code to view its specific billing and regulatory data.

67877-751-81
1 KIT in 1 CARTON * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g 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 67877-751-58 identifies a specific commercial package of 1 kit in 1 carton * 145 ml in 1 bottle * 15 g in 1 bottle * 289 ml in 1 bottle * 7.5 g in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Ascend Laboratories, Llc. This kit is formulated for use and contains 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 Ascend Laboratories, Llc on August 01, 2023. The current certification is valid through December 31, 2026.

How is this Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877075158. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
67877-751-58
11-Digit CMS (5-4-2)
67877-0751-58

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