Diphenoxylate Hydrochloride And Atropine Sulfate
NDC Package 12634-531-97

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

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

Diphenoxylate Hydrochloride And Atropine Sulfate is tablets, USP are effective as adjunctive therapy in the management of diarrhea. Marketed by Apotheca Inc., this product is identified by NDC 12634-531 and is authorized under FDA application ANDA085762.

Identification & Billing

NDC Package Code
12634-531-97
Package Description
7 TABLET in 1 BOTTLE
Product Code
12634-531
11-Digit Billing Format
12634053197
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 and atropine sulfate tablets, USP are effective as adjunctive therapy in the management of diarrhea.

Regulatory & Marketing

Labeler Name
Apotheca Inc.
FDA Application #
ANDA085762
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-1977
Listing Expiration
12-31-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (12634-531). Click a package code to view its specific billing and regulatory data.

12634-531-00
10 TABLET in 1 BOTTLE
12634-531-50
50 TABLET in 1 BOTTLE
12634-531-54
14 TABLET in 1 BLISTER PACK
12634-531-55
15 TABLET in 1 BLISTER PACK
12634-531-59
30 TABLET in 1 BLISTER PACK
12634-531-60
60 TABLET in 1 BOTTLE
12634-531-61
10 TABLET in 1 BLISTER PACK
12634-531-79
25 TABLET in 1 BOTTLE
12634-531-80
20 TABLET in 1 BOTTLE
12634-531-82
12 TABLET in 1 BOTTLE
12634-531-91
1 TABLET in 1 BLISTER PACK
12634-531-95
5 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 12634-531-97 identifies a specific commercial package of 7 tablet in 1 bottle of Diphenoxylate Hydrochloride And Atropine Sulfate, labeled by Apotheca Inc.. 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 Apotheca Inc. on November 17, 1977. The current certification is valid through December 31, 2020.

How is this Apotheca Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634053197. 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)
12634-531-97
11-Digit CMS (5-4-2)
12634-0531-97

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