Loperamide Hydrochloride Capsule, Liquid Filled
NDC Package 43598-770-24

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

Package Information

Loperamide Hydrochloride capsules is drink plenty of clear fluids to help prevent dehydration caused by diarrhea.not for use in children under 12 years of ageadults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-770 and is authorized under FDA application ANDA213070.

Identification & Billing

NDC Package Code
43598-770-24
Package Description
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
43598-770
11-Digit Billing Format
43598077024
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.not for use in children under 12 years of ageadults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA213070
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-22-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43598-770-24 identifies a specific commercial package of 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Loperamide Hydrochloride, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. This capsule, liquid filled 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 Dr. Reddy's Laboratories Inc. on October 22, 2021. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598077024. 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)
43598-770-24
11-Digit CMS (5-4-2)
43598-0770-24

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