Loperamide Hydrochloride Solution
NDC Package 81033-067-35

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 solution is 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 Kesin Pharma Corporation, this product is identified by NDC 81033-067 and is authorized under FDA application ANDA220100.

Identification & Billing

NDC Package Code
81033-067-35
Package Description
30 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15)
Product Code
81033-067
11-Digit Billing Format
81033006735
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
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 hours children 9 years to 11 years (60 lbs to 95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6 years to 8 years (48 lbs to 59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2 years to 5 years (34 lbs to 47 lbs) ask a doctorchildren under 2 years (up to 33 lbs) do not use

Regulatory & Marketing

Labeler Name
Kesin Pharma Corporation
Product Type
Human Otc Drug
FDA Application #
ANDA220100
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-13-2024
Listing Expiration
12-31-2027
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 (81033-067). Click a package code to view its specific billing and regulatory data.

81033-067-34
30 CUP, UNIT-DOSE in 1 CARTON / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07)

* 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 81033-067-35 identifies a specific commercial package of 30 cup, unit-dose in 1 carton / 15 ml in 1 cup, unit-dose (81033-067-15) of Loperamide Hydrochloride, a human over the counter drug labeled by Kesin Pharma Corporation. 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 Kesin Pharma Corporation on November 13, 2024. The current certification is valid through December 31, 2027.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033006735. 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)
81033-067-35
11-Digit CMS (5-4-2)
81033-0067-35

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