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  4. NDC Product Code: 0280-0083 Alka-seltzer Heartburn Relief Lemon Lime

NDC 0280-0083 Alka-seltzer Heartburn Relief Lemon Lime

Anhydrous Citric Acid,Sodium Bicarbonate (heat-treated) Tablet, Effervescent Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0280-0083?
  4. Alka-seltzer Heartburn Relief Lemon Lime Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes

Product Information

NDC Product Code:
0280-0083
Proprietary Name:
Alka-seltzer Heartburn Relief Lemon Lime
Non-Proprietary Name: [1]
Anhydrous Citric Acid, Sodium Bicarbonate (heat-treated)
Substance Name: [2]
Citric Acid Monohydrate; Sodium Bicarbonate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Bayer Healthcare Llc
    Labeler Code:
    0280
    Product Label ID:
    cc21af24-9a5b-6831-e053-2a95a90a0af4
    FDA Application Number: [6]
    M001
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-16-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 0280-0083?

    The NDC code 0280-0083 is assigned by the FDA to the product Alka-seltzer Heartburn Relief Lemon Lime which is a human over the counter drug product labeled by Bayer Healthcare Llc. The generic name of Alka-seltzer Heartburn Relief Lemon Lime is anhydrous citric acid, sodium bicarbonate (heat-treated). The product's dosage form is tablet, effervescent and is administered via oral form. The product is distributed in a single package with assigned NDC code 0280-0083-01 18 packet in 1 carton / 2 tablet, effervescent in 1 packet. 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 Alka-seltzer Heartburn Relief Lemon Lime?

    Uses for the relief of heartburnacid indigestionsour stomachupset stomach associated with these symptoms

    What are Alka-seltzer Heartburn Relief Lemon Lime 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.
    • CITRIC ACID MONOHYDRATE 1000 mg/1 - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
    • SODIUM BICARBONATE 1650 mg/1 - A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

    What is the NDC to RxNorm Crosswalk for Alka-seltzer Heartburn Relief Lemon Lime?

    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: 2599360 - citric acid 1000 MG / sodium bicarbonate 1650 MG Effervescent Oral Tablet
    • RxCUI: 2599360 - citric acid 1000 MG / NaHCO3 1650 MG Effervescent Oral Tablet

    Which are the Pharmacologic Classes for Alka-seltzer Heartburn Relief Lemon Lime?

    * 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".