Loperamide Hydrochloride And Simethicone Tablet
NDC Package 81522-325-24

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

Package Information

Loperamide Hydrochloride And 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 Fsa Store Inc, this product is identified by NDC 81522-325 and is authorized under FDA application ANDA211438.

Identification & Billing

NDC Package Code
81522-325-24
Package Description
4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code
81522-325
11-Digit Billing Format
81522032524
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
Loperamide Hydrochloride And Simethicone
Non-Proprietary Name
Loperamide Hydrochloride And 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 over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in  24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

Regulatory & Marketing

Labeler Name
Fsa Store Inc
Product Type
Human Otc Drug
FDA Application #
ANDA211438
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2024
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 81522-325-24 identifies a specific commercial package of 4 blister pack in 1 carton / 6 tablet in 1 blister pack of Loperamide Hydrochloride And Simethicone, a human over the counter drug labeled by Fsa Store Inc. 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 Fsa Store Inc on June 30, 2024. The current certification is valid through December 31, 2026.

How is this Fsa Store Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522032524. 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)
81522-325-24
11-Digit CMS (5-4-2)
81522-0325-24

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