Hemorrhoidal Suppository
NDC Package 70795-1021-4

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

Hemorrhoidal (cocoa butter, phenylephrine hydrochloride) suppositories is detach one suppository from the strip. This formulation utilizes a suppository delivery system. Marketed by Graxcell Pharmaceutical, Llc, this product is identified by NDC 70795-1021 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
70795-1021-4
Package Description
24 BLISTER PACK in 1 BOX / 1 SUPPOSITORY in 1 BLISTER PACK
Product Code
70795-1021
11-Digit Billing Format
70795102104
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: 1438497 - cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository
  • RxCUI: 1438497 - cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository

Clinical Specifications

Proprietary Name
Hemorrhoidal
Non-Proprietary Name
Cocoa Butter, Phenylephrine Hydrochloride
Substance Name
Cocoa Butter; Phenylephrine Hydrochloride
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Detach one suppository from the strip. Remove the wrapper before inserting into the rectum.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 of age: consult doctor

Regulatory & Marketing

Labeler Name
Graxcell Pharmaceutical, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-29-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 (70795-1021). Click a package code to view its specific billing and regulatory data.

70795-1021-2
12 BLISTER PACK in 1 BOX / 1 SUPPOSITORY in 1 BLISTER PACK

* 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 70795-1021-4 identifies a specific commercial package of 24 blister pack in 1 box / 1 suppository in 1 blister pack of Hemorrhoidal, a human over the counter drug labeled by Graxcell Pharmaceutical, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 24 billable units per package. This suppository is formulated for rectal use and contains cocoa butter; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Graxcell Pharmaceutical, Llc on March 29, 2017. The current certification is valid through December 31, 2026.

How is this Graxcell Pharmaceutical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70795102104. 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 (5-4-1)
70795-1021-4
11-Digit CMS (5-4-2)
70795-1021-04

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