Diphenoxylate Hydrochloride And Atropine Sulfate Tablet
NDC Package 72189-336-30

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

Diphenoxylate Hydrochloride And Atropine Sulfate tablets are contraindicated in:Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS). This formulation utilizes a tablet delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-336 and is authorized under FDA application ANDA213413.

Identification & Billing

NDC Package Code
72189-336-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
72189-336
11-Digit Billing Format
72189033630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1190572 - diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet
  • RxCUI: 1190572 - atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet

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 contraindicated in:Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS). Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS). Patients with known hypersensitivity to diphenoxylate or atropine. Patients with obstructive jaundice.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
ANDA213413
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-07-2022
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 (72189-336). Click a package code to view its specific billing and regulatory data.

72189-336-10
10 TABLET in 1 BOTTLE

* 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 72189-336-30 identifies a specific commercial package of 30 tablet in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Direct Rx on March 07, 2022. The current certification is valid through December 31, 2026.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189033630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
72189-336-30
11-Digit CMS (5-4-2)
72189-0336-30

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