Emetrol Powder Powder, For Solution
NDC Package 65197-203-09

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Emetrol Powder (sodium citrate dihydrate) powders is ▪Adults: 1-2 packets 3 to 4 times a day. This formulation utilizes a powder, for solution delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-203.

Identification & Billing

NDC Package Code
65197-203-09
Package Description
6 POWDER, FOR SOLUTION in 1 CARTON
Product Code
65197-203
11-Digit Billing Format
65197020309
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Emetrol Powder Non-drowsy
Non-Proprietary Name
Sodium Citrate Dihydrate
Substance Name
Trisodium Citrate Dihydrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRISODIUM CITRATE DIHYDRATE 460 mg/1
Pharmacologic Class
Usage Information
▪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.

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
12-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65197-203-09 identifies a specific commercial package of 6 powder, for solution in 1 carton of Emetrol Powder Non-drowsy, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This powder, for solution is formulated for oral use and contains trisodium citrate dihydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Wellspring Pharmaceutical Corporation on December 01, 2023. The current certification is valid through December 31, 2026.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197020309. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65197-203-09
11-Digit CMS (5-4-2)
65197-0203-09

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.