Emetrol Powder Powder, For Solution
NDC 65197-203

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65197-203?
  5. Emetrol Powder Non-drowsy Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Emetrol Powder (sodium citrate dihydrate) is a UNAPPROVED DRUG OTHER-approved product labeled by Wellspring Pharmaceutical Corporation. This medication is typically used as a acidifying activity [moa]. It is supplied as a white powder, for solution for oral administration. This product entry covers the primary NDC 65197-203 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65197-203
Proprietary Name:
Emetrol Powder Non-drowsy
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
Code Navigator:

Clinical Specifications

Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
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:
9d8d2ee7-9db7-4be7-8c73-511eb2e32459
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]
12-01-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Imprint(s):
NONE
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 65197-203?

The NDC code 65197-203 is assigned by the FDA to the product Emetrol Powder Non-drowsy. It is commonly known by its generic name, sodium citrate dihydrate. This pharmaceutical product is labeled by Wellspring Pharmaceutical Corporation and is currently categorized as listed product. The medication is a powder, for solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 65197-203-09. 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?

▪Adults: 1-2 packets 3 to 4 times a day. ▪Children: Consult a doctor for appropriate dosage.▪Dosage may be repeated after 15 minutes, not to exceed 4 packets in a 24-hour period unless advised by a doctor.▪Dissolve contents of one (1) packet in 4 oz. of room temperature water before consumption. Stir again if needed▪Read all package directions and warnings before use and use only as directed.

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.
  • TRISODIUM CITRATE DIHYDRATE 460 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 the associated 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 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:

Which are the Pharmacologic Classes of this product?

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.

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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".