Loperamide Hydrochloride Solution
NDC Package 68094-129-62

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

Package Information

Loperamide Hydrochloride solution is use as directed per healthcare professional.drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. This formulation utilizes a solution delivery system. Marketed by Precision Dose, Inc., this product is identified by NDC 68094-129 and is authorized under FDA application ANDA091292.

Identification & Billing

NDC Package Code
68094-129-62
Package Description
3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59)
Product Code
68094-129
11-Digit Billing Format
68094012962
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
Pharmacologic Class
Usage Information
Use as directed per healthcare professional.drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise use age.shake well before usingmL = milliliteradults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hourschildren 9-11 years (60-95 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hourschildren 6-8 years (48-59 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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
Precision Dose, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA091292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2020
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 68094-129-62 identifies a specific commercial package of 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose (68094-129-59) of Loperamide Hydrochloride, a human over the counter drug labeled by Precision Dose, Inc.. This solution is formulated for oral use and contains 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 Precision Dose, Inc. on May 18, 2020. The current certification is valid through December 31, 2026.

How is this Precision Dose, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68094012962. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68094-129-62
11-Digit CMS (5-4-2)
68094-0129-62

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