Diphenoxylate Hydrochloride And Atropine Sulfate Tablet
NDC Package 67296-2240-5

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

Package Information

Diphenoxylate Hydrochloride And Atropine Sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. This formulation utilizes a tablet delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2240 and is authorized under FDA application ANDA213413.

Identification & Billing

NDC Package Code
67296-2240-5
Package Description
15 TABLET in 1 BOTTLE
Product Code
67296-2240
11-Digit Billing Format
67296224005

Clinical Specifications

Proprietary Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Substance Name
Atropine Sulfate; Diphenoxylate 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
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA213413
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-15-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2240-5 identifies a specific commercial package of 15 tablet in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, a human prescription drug labeled by Redpharm Drug. This tablet is formulated for oral use and contains atropine sulfate; diphenoxylate 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 Redpharm Drug on March 15, 2020. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296224005. 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 (5-4-1)
67296-2240-5
11-Digit CMS (5-4-2)
67296-2240-05

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