Vancomycin Hydrochloride Capsule
NDC Package 0121-1032-50

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 capsules is vancomycin hydrochloride capsule is indicated for the treatment of Clostridioides difficile-associated diarrhea. This formulation utilizes a capsule delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-1032 and is authorized under FDA application ANDA065478.

Identification & Billing

NDC Package Code
0121-1032-50
Package Description
50 CAPSULE in 1 BOTTLE
Product Code
0121-1032
11-Digit Billing Format
00121103250
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vancomycin Hydrochloride
Non-Proprietary Name
Vancomycin Hydrochloride
Substance Name
Vancomycin Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VANCOMYCIN HYDROCHLORIDE 125 mg/1
Pharmacologic Class
Usage Information
Vancomycin hydrochloride capsule is indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsule is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsule must be given orally for these infections. • Orally administered vancomycin hydrochloride capsule is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsule and other antibacterial drugs, vancomycin hydrochloride capsule 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
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA065478
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2026
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 (0121-1032). Click a package code to view its specific billing and regulatory data.

0121-1032-20
2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

* 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 0121-1032-50 identifies a specific commercial package of 50 capsule in 1 bottle of Vancomycin Hydrochloride, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This capsule 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 Pai Holdings, Llc Dba Pai Pharma on May 01, 2026. The current certification is valid through December 31, 2027.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121103250. 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 (4-4-2)
0121-1032-50
11-Digit CMS (5-4-2)
00121-1032-50

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