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  4. NDC Product Code: 49631-178 Ohtas Isan Antacid

NDC 49631-178 Ohtas Isan Antacid

Calcium Carbonate,Sodium Bicarbonate Powder Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49631-178?
  4. Ohtas Isan Antacid Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
49631-178
Proprietary Name:
Ohtas Isan Antacid
Non-Proprietary Name: [1]
Calcium Carbonate, Sodium Bicarbonate
Substance Name: [2]
Calcium Carbonate; Sodium Bicarbonate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Ohta's Isan Co.,ltd.
    Labeler Code:
    49631
    Product Label ID:
    8723fe90-8402-4511-b6c6-b71cf98513e3
    FDA Application Number: [6]
    part331
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    10-16-2000
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 49631-178-13

    Package Description: 1 DOSE PACK in 1 BOX / 16 PACKET in 1 DOSE PACK / 1.3 g in 1 PACKET

    NDC Code 49631-178-21

    Package Description: 1 CAN in 1 BOX / 75 g in 1 CAN

    NDC Code 49631-178-22

    Package Description: 1 CAN in 1 BOX / 140 g in 1 CAN

    Product Details

    What is NDC 49631-178?

    The NDC code 49631-178 is assigned by the FDA to the product Ohtas Isan Antacid which is a human over the counter drug product labeled by Ohta's Isan Co.,ltd.. The generic name of Ohtas Isan Antacid is calcium carbonate, sodium bicarbonate. The product's dosage form is powder and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 49631-178-13 1 dose pack in 1 box / 16 packet in 1 dose pack / 1.3 g in 1 packet, 49631-178-21 1 can in 1 box / 75 g in 1 can, 49631-178-22 1 can in 1 box / 140 g in 1 can. 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 Ohtas Isan Antacid?

    This product is used as Antacid Antacid . Relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms

    What are Ohtas Isan Antacid 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.
    • CALCIUM CARBONATE 1 g/g - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
    • SODIUM BICARBONATE 1 g/g - A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.
    • CALCIUM CARBONATE 1 g/g - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
    • SODIUM BICARBONATE 1 g/g - A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

    Which are Ohtas Isan Antacid UNII Codes?

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

    Which are Ohtas Isan Antacid 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 Ohtas Isan Antacid?

    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: 1361708 - calcium carbonate 497 MG / sodium bicarbonate 600 MG Oral Powder
    • RxCUI: 1361708 - Calcium Carbonate 497 MG / NaHCO3 600 MG Oral Powder

    Which are the Pharmacologic Classes for Ohtas Isan Antacid?

    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

    Calcium Carbonate


    Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    Sodium Bicarbonate


    Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".