Diphenoxylate Hcl And Atropine Sulfate
NDC Package 16590-080-30

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 Hcl And Atropine Sulfate is iNDICATIONS AND USAGEDiphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea. Marketed by Stat Rx Usa, this product is identified by NDC 16590-080 and is authorized under FDA application ANDA086727.

Identification & Billing

NDC Package Code
16590-080-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
16590-080
11-Digit Billing Format
16590008030
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 Hcl And Atropine Sulfate
Dosage Form
-
Usage Information
INDICATIONS AND USAGEDiphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea

Regulatory & Marketing

Labeler Name
Stat Rx Usa
FDA Application #
ANDA086727
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-29-1979
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 16590-080-30 identifies a specific commercial package of 30 tablet in 1 bottle of Diphenoxylate Hcl And Atropine Sulfate, labeled by Stat Rx Usa. 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 Stat Rx Usa on October 29, 1979. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590008030. 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)
16590-080-30
11-Digit CMS (5-4-2)
16590-0080-30

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