Propoxyphene Napsylate And Acetaminophen
NDC Package 12634-537-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Propoxyphene Napsylate And Acetaminophen is tablets are indicated for the relief of mild to moderate pain. Marketed by Apotheca, Inc., this product is identified by NDC 12634-537 and is authorized under FDA application ANDA074119.

Identification & Billing

NDC Package Code
12634-537-91
Package Description
1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
11-Digit Billing Format
12634053791
RxNorm Crosswalk
  • RxCUI: 828576 - propoxyphene napsylate 100 MG / acetaminophen 650 MG Oral Tablet
  • RxCUI: 828576 - acetaminophen 650 MG / propoxyphene napsylate 100 MG Oral Tablet
  • RxCUI: 828576 - APAP 650 MG / propoxyphene napsylate 100 MG (propoxyphene hydrochloride 65 MG) Oral Tablet
  • RxCUI: 828576 - APAP 650 MG / propoxyphene napsylate 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Propoxyphene Napsylate And Acetaminophen
Dosage Form
-
Usage Information
Propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain.

Regulatory & Marketing

Labeler Name
Apotheca, Inc.
FDA Application #
ANDA074119
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (12634-537). Click a package code to view its specific billing and regulatory data.

10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
15 TABLET, FILM COATED in 1 BLISTER PACK
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
9 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 12634-537-91 identifies a specific commercial package of 1 tablet, film coated in 1 blister pack of Propoxyphene Napsylate And Acetaminophen, 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 January 01, 2009. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634053791. 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)
12634-537-91
11-Digit CMS (5-4-2)
12634-0537-91

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