Emetrol Chewables Tablet, Chewable
NDC Package 65197-204-42

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

Package Information

Emetrol Chewables (sodium citrate dihydrate) tablets is adults: 2-4 tablets. This formulation utilizes a tablet, chewable delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-204.

Identification & Billing

NDC Package Code
65197-204-42
Package Description
1 BOTTLE in 1 BOX / 42 TABLET, CHEWABLE in 1 BOTTLE
Product Code
65197-204
11-Digit Billing Format
65197020442
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Emetrol Chewables
Non-Proprietary Name
Sodium Citrate Dihydrate
Substance Name
Trisodium Citrate Dihydrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRISODIUM CITRATE DIHYDRATE 230 mg/1
Pharmacologic Class
Usage Information
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.

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
03-15-2022
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 65197-204-42 identifies a specific commercial package of 1 bottle in 1 box / 42 tablet, chewable in 1 bottle of Emetrol Chewables, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, chewable 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 March 15, 2022. 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: 65197020442. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
65197-204-42
11-Digit CMS (5-4-2)
65197-0204-42

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