Diphenoxylate Hydrochloride And Atropine Sulfate Solution
NDC Package 0054-3194-46

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 solution is diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-3194 and is authorized under FDA application ANDA087708.

Identification & Billing

NDC Package Code
0054-3194-46
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
0054-3194
11-Digit Billing Format
00054319446
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1190568 - atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution

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
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)
Pharmacologic Class
Usage Information
Diphenoxylate hydrochloride and atropine sulfate is effective as adjunctive therapy in the management of diarrhea.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA087708
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-03-1982
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 0054-3194-46 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This solution 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 Hikma Pharmaceuticals Usa Inc. on May 03, 1982. The current certification is valid through December 31, 2027.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054319446. 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 (4-4-2)
0054-3194-46
11-Digit CMS (5-4-2)
00054-3194-46

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