Loperamide Hydrochloride And Simethicone Tablet
NDC Package 69452-210-04

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

Package Information

Loperamide Hydrochloride And Simethicone tablets is drink plenty of clear fluids to help prevent dehydration caused by diarrheatake only on an empty stomach (1 hour before or 2 hours after a meal)take with a full (8 oz.) glass of waterfind right dose on chart below. This formulation utilizes a tablet delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-210 and is authorized under FDA application ANDA213484.

Identification & Billing

NDC Package Code
69452-210-04
Package Description
1 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code
69452-210
11-Digit Billing Format
69452021004
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 diarrheatake only on an empty stomach (1 hour before or 2 hours after a meal)take with a full (8 oz.) glass of waterfind 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 hours children 9 years to 11 years (60 lbs to 95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6 years to 8 years (48 lbs to 59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2 years to 5 years (34 lbsto 47 lbs) ask a doctorchildren under 2 years (up to 33 lbs) do not use

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA213484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69452-210). Click a package code to view its specific billing and regulatory data.

69452-210-12
4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

* 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 69452-210-04 identifies a specific commercial package of 1 blister pack in 1 carton / 6 tablet in 1 blister pack of Loperamide Hydrochloride And Simethicone, a human over the counter drug labeled by Bionpharma 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 Bionpharma Inc. on December 01, 2021. The current certification is valid through December 31, 2026.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452021004. 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)
69452-210-04
11-Digit CMS (5-4-2)
69452-0210-04

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