1. Home
  2. Labeler Index
  3. Allergan, Inc.
  4. NDC Product Code: 58914-601 Pylera

NDC 58914-601 Pylera

Bismuth Subcitrate Potassium,Metronidazole,Tetracycline Hydrochloride Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58914-601?
  5. Pylera Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
58914-601
Proprietary Name:
Pylera
Non-Proprietary Name: [1]
Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride
Substance Name: [2]
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Allergan, Inc.
    Labeler Code:
    58914
    Product Label ID:
    a762e164-b390-4e8c-bd46-bf6c31eeb486
    FDA Application Number: [6]
    NDA050786
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-01-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - OPAQUE WHITE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    22 MM
    Imprint(s):
    APTALIS;BMT
    Score:
    1

    Product Packages

    NDC Code 58914-601-20

    Package Description: 1 BLISTER PACK in 1 BOX / 120 CAPSULE in 1 BLISTER PACK

    Price per Unit: $2.42805 per EA

    NDC Code 58914-601-21

    Package Description: 1 BOTTLE in 1 BOX / 120 CAPSULE in 1 BOTTLE

    Product Details

    What is NDC 58914-601?

    The NDC code 58914-601 is assigned by the FDA to the product Pylera which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Pylera is bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 58914-601-20 1 blister pack in 1 box / 120 capsule in 1 blister pack, 58914-601-21 1 bottle in 1 box / 120 capsule in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Pylera?

    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.

    What are Pylera Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Pylera UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Pylera Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Pylera?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Pylera?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Bismuth, Metronidazole, and Tetracycline


    Bismuth, metronidazole, and tetracycline is used along with other ulcer medications to treat duodenal ulcers. It is in a class of medications called antibacterial agents. It works by preventing the growth and spread of Helicobacter pylori bacteria, which often occurs with ulcers. Treating this infection keeps ulcers from coming back.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".