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  4. NDC Product Code: 65197-204 Emetrol Chewables

NDC 65197-204 Emetrol Chewables

Sodium Citrate Dihydrate Tablet, Chewable Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65197-204?
  5. Emetrol Chewables Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
65197-204
Proprietary Name:
Emetrol Chewables
Non-Proprietary Name: [1]
Sodium Citrate Dihydrate
Substance Name: [2]
Trisodium Citrate Dihydrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Wellspring Pharmaceutical Corporation
    Labeler Code:
    65197
    Product Label ID:
    9880a18a-cf84-47cd-99b5-d692065a25bf
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    03-15-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    16 MM
    Imprint(s):
    CB2
    Score:
    1
    Flavor(s):
    LEMON (C73396)

    Product Packages

    NDC Code 65197-204-42

    Package Description: 1 BOTTLE in 1 BOX / 42 TABLET, CHEWABLE in 1 BOTTLE

    Product Details

    What is NDC 65197-204?

    The NDC code 65197-204 is assigned by the FDA to the product Emetrol Chewables which is a human over the counter drug product labeled by Wellspring Pharmaceutical Corporation. The generic name of Emetrol Chewables is sodium citrate dihydrate. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 65197-204-42 1 bottle in 1 box / 42 tablet, chewable 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 Emetrol Chewables?

    Adults: 2-4 tablets. Children: Consult a doctor for appropriate dosage.Chew tablets completely. Do not swallow whole Dosage may be repeated after 15 minutes, not to exceed 24 tablets in a 24-hour period unless advised by a doctor.Read all package directions and warnings before use and use only as directed. These tablets are intended for use by normally healthy persons only.Persons under 18 years of age should use only as directed by a doctor.

    What are Emetrol Chewables 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.
    • TRISODIUM CITRATE DIHYDRATE 230 mg/1 - Sodium salts of citric acid that are used as buffers and food preservatives. They are used medically as anticoagulants in stored blood, and for urine alkalization in the prevention of KIDNEY STONES.

    Which are Emetrol Chewables UNII Codes?

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

    • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
    • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Active Moiety)

    Which are Emetrol Chewables 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 Emetrol Chewables?

    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:

    Which are the Pharmacologic Classes for Emetrol Chewables?

    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.

    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.

    [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".