Formulation R
NDC Package 0713-0535-24

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.

Formulation R is adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Marketed by G&w Laboratories, Inc., this product is identified by NDC 0713-0535 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
0713-0535-24
Package Description
24 SUPPOSITORY in 1 CARTON
Product Code
0713-0535
11-Digit Billing Format
00713053524
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA
RxNorm Crosswalk
  • RxCUI: 2715398 - phenylephrine hydrochloride 0.25 % Rectal Suppository
  • RxCUI: 2715398 - phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository

Clinical Specifications

Proprietary Name
Formulation R
Dosage Form
-
Usage Information
Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or a soft cloth before insertion of the product.• remove wrapper before inserting into the rectum as follows:                                  • hold suppository with pointed end up                  • carefully separate tabs with fingernail                  • slowly pull apart by pulling tabs down on both sides                  • remove suppository from wrapper• insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement• children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
G&w Laboratories, Inc.
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-24-2002
Listing Expiration
12-31-2018
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 (0713-0535). Click a package code to view its specific billing and regulatory data.

0713-0535-12
12 SUPPOSITORY in 1 CARTON

* 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 0713-0535-24 identifies a specific commercial package of 24 suppository in 1 carton of Formulation R, labeled by G&w Laboratories, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 24 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 G&w Laboratories, Inc. on June 24, 2002. The current certification is valid through December 31, 2018.

How is this G&w Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713053524. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 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 (4-4-2)
0713-0535-24
11-Digit CMS (5-4-2)
00713-0535-24

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