Quadrapax
NDC Package 21695-970-16

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.

Quadrapax is fDA has classified the following indications as "possibly" effective:  For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  May also be useful as adjunctive therapy in the treatment of duodenal ulcer.  IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-970.

Identification & Billing

NDC Package Code
21695-970-16
Package Description
473 mL in 1 BOTTLE
Product Code
21695-970
11-Digit Billing Format
21695097016
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1046787 - PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution
  • RxCUI: 1046787 - atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution
  • RxCUI: 1046787 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Quadrapax
Dosage Form
-
Usage Information
FDA has classified the following indications as "possibly" effective:  For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  May also be useful as adjunctive therapy in the treatment of duodenal ulcer.  IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-06-2011
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 21695-970-16 identifies a specific commercial package of 473 ml in 1 bottle of Quadrapax, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 473 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 Rebel Distributors Corp on May 06, 2011. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695097016. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
21695-970-16
11-Digit CMS (5-4-2)
21695-0970-16

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