Pylera Capsule
NDC Package 61269-381-12

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

Package Information

Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) capsules is this combination medication is used with an acid blocker (for example, a proton pump inhibitor such as omeprazole). This formulation utilizes a capsule delivery system. Marketed by H2-pharma, Llc, this product is identified by NDC 61269-381 and is authorized under FDA application NDA050786.

Identification & Billing

NDC Package Code
61269-381-12
Package Description
10 BLISTER PACK in 1 BOX / 12 CAPSULE in 1 BLISTER PACK
Product Code
61269-381
11-Digit Billing Format
61269038112
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk
  • RxCUI: 1294619 - bismuth subcitrate 140 MG / metroNIDAZOLE 125 MG / tetracycline HCl 125 MG Oral Capsule
  • RxCUI: 1294619 - bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule
  • RxCUI: 1294621 - PYLERA 140 MG / 125 MG / 125 MG Oral Capsule
  • RxCUI: 1294621 - bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]
  • RxCUI: 1294621 - Pylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Pylera
Non-Proprietary Name
Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline Hydrochloride
Substance Name
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline 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)
Pharmacologic Class
Usage Information
This combination medication is used with an acid blocker (for example, a proton pump inhibitor such as omeprazole). It is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and tetracycline. Bismuth subcitrate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. Metronidazole and tetracycline are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. This product treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This product is not recommended for use in children.

Regulatory & Marketing

Labeler Name
H2-pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA050786
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-18-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61269-381-12 identifies a specific commercial package of 10 blister pack in 1 box / 12 capsule in 1 blister pack of Pylera, a human prescription drug labeled by H2-pharma, Llc. This capsule is formulated for oral use and contains bismuth subcitrate potassium; metronidazole; tetracycline 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 H2-pharma, Llc on August 18, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This combination medication is used with an acid blocker (for example, a proton pump inhibitor such as omeprazole). It is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and tetracycline. Bismuth subcitrate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. Metronidazole and tetracycline are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. This product treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This product is not recommended for use in children.

How is this H2-pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61269038112. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (5-3-2)
61269-381-12
11-Digit CMS (5-4-2)
61269-0381-12

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