Equaline Anti Diarrheal Plus Anti Gas Tablet
NDC Package 41163-553-89

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

Package Information

Equaline Anti Diarrheal Plus Anti Gas (loperamide hydrochloride, simethicone) tablets is •drink plenty of clear fluids to help prevent dehydration caused by diarrhea•take only on an empty stomach (1 hour before or 2 hours after a meal)•take with a full (8 oz.) glass of water•find right dose on chart below. This formulation utilizes a tablet delivery system. Marketed by United Natural Foods, Inc. Dba Unfi, this product is identified by NDC 41163-553 and is authorized under FDA application ANDA209837.

Identification & Billing

NDC Package Code
41163-553-89
Package Description
18 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
41163-553
11-Digit Billing Format
41163055389
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
18 EA
RxNorm Crosswalk
  • RxCUI: 978001 - loperamide HCl 2 MG / simethicone 125 MG Oral Tablet
  • RxCUI: 978001 - loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet

Clinical Specifications

Proprietary Name
Equaline Anti Diarrheal Plus Anti Gas
Non-Proprietary Name
Loperamide Hydrochloride, Simethicone
Substance Name
Dimethicone; Loperamide Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•drink plenty of clear fluids to help prevent dehydration caused by diarrhea•take only on an empty stomach (1 hour before or 2 hours after a meal)•take with a full (8 oz.) glass of water•find right dose on chart below. If possible, use weight to dose; otherwise, use age.adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hourschildren 9-11 years (60-95 lbs)1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6-8 years (48-59 lbs)1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hourschildren 2-5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use

Regulatory & Marketing

Labeler Name
United Natural Foods, Inc. Dba Unfi
Product Type
Human Otc Drug
FDA Application #
ANDA209837
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2019
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 41163-553-89 identifies a specific commercial package of 18 blister pack in 1 carton / 1 tablet in 1 blister pack of Equaline Anti Diarrheal Plus Anti Gas, a human over the counter drug labeled by United Natural Foods, Inc. Dba Unfi. This product is billed for "EA" each discreet unit and contains an estimated amount of 18 billable units per package. This tablet is formulated for oral use and contains dimethicone; loperamide hydrochloride 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 United Natural Foods, Inc. Dba Unfi on December 04, 2019. The current certification is valid through December 31, 2026.

How is this United Natural Foods, Inc. Dba Unfi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41163055389. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 18 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)
41163-553-89
11-Digit CMS (5-4-2)
41163-0553-89

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