Diphenoxylate Hydrochloride And Atropine Sulfate
NDC Package 61919-080-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diphenoxylate Hydrochloride And Atropine Sulfate is diphenoxylate hydrochloride is effective as adjunctive therapy in the management of diarrhea. Marketed by Direct Rx, this product is identified by NDC 61919-080 and is authorized under FDA application NDA012462.

Identification & Billing

NDC Package Code
61919-080-10
Package Description
10 TABLET in 1 BOTTLE
Product Code
61919-080
11-Digit Billing Format
61919008010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 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
Dosage Form
-
Usage Information
Diphenoxylate hydrochloride is effective as adjunctive therapy in the management of diarrhea.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
NDA012462
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-01-2015
Listing Expiration
12-31-2017
Exclude Flag
I
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 61919-080-10 identifies a specific commercial package of 10 tablet in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct Rx on January 01, 2015. The current certification is valid through December 31, 2017.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919008010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
61919-080-10
11-Digit CMS (5-4-2)
61919-0080-10

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