Emetrol Children Mixed Berry Solution
NDC 65197-202

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65197-202?
  5. Emetrol Children Mixed Berry Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

Emetrol Children Mixed Berry (phosphorated carbohydrate) is a UNAPPROVED DRUG OTHER-approved product labeled by Wellspring Pharmaceutical Corporation. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a red solution for oral administration. This product entry covers the primary NDC 65197-202 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65197-202
Proprietary Name:
Emetrol Children Mixed Berry
Non-Proprietary Name: [1]
Phosphorated Carbohydrate
Substance Name: [2]
Dextrose; Fructose; Phosphoric Acid
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Wellspring Pharmaceutical Corporation
Labeler Code:
65197
Product Label ID:
ecff699b-d4d8-4407-8119-3e9a1100024a
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
06-01-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 65197-202?

The NDC code 65197-202 is assigned by the FDA to the product Emetrol Children Mixed Berry. It is commonly known by its generic name, phosphorated carbohydrate. This pharmaceutical product is labeled by Wellspring Pharmaceutical Corporation and is currently categorized as listed product. The medication is a solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 65197-202-14. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

For maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this productrepeat dose every 15 minutes or until distress subsidesChild should not take more than 5 doses in 1 hour without consulting a doctormeasure only with dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products. mL= milliliterchildren under 2 years - Do not use children 2 to under 12 years of age - 5 mL or 10mLchildren 12 years of age and over - 15 mL or 30 mL

What are Active Ingredients of this product?

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.
  • DEXTROSE 1.87 g/5mL
  • FRUCTOSE 1.87 g/5mL - A monosaccharide in sweet fruits and honey that is soluble in water, alcohol, or ether. It is used as a preservative and an intravenous infusion in parenteral feeding.
  • PHOSPHORIC ACID 21.5 mg/5mL - Inorganic derivatives of phosphoric acid (H3PO4). Note that organic derivatives of phosphoric acids are listed under ORGANOPHOSPHATES.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 318146 - dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG in 5 mL Oral Solution
  • RxCUI: 318146 - fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral Solution
  • RxCUI: 318146 - dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG per 5 ML Oral Solution
  • RxCUI: 809602 - Emetrol 1.87 GM / 1.87 GM / 21.5 MG in 5 mL Oral Solution
  • RxCUI: 809602 - fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral Solution [Emetrol]

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".