Rectasmoothe
NDC Package 69315-301-30

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 discontinued by the firm.

Rectasmoothe is when practical, clean area with mild soap and warm water and rinse thouroughly. Marketed by Leading Pharma, Llc, this product is identified by NDC 69315-301 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
69315-301-30
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
69315-301
11-Digit Billing Format
69315030130
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM

Clinical Specifications

Proprietary Name
Rectasmoothe
Dosage Form
-
Usage Information
When practical, clean area with mild soap and warm water and rinse thouroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.Adults and children 12 years and older: Apply externally to the affected area up to six times a day.Children under 12 years of age: Consult a doctorTo use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.

Regulatory & Marketing

Labeler Name
Leading Pharma, Llc
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2011
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
Exclude Flag
D
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 69315-301-30 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Rectasmoothe, labeled by Leading Pharma, Llc. 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 Leading Pharma, Llc on April 01, 2011. The current certification is valid through April 30, 2026.

How is this Leading Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69315030130. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
69315-301-30
11-Digit CMS (5-4-2)
69315-0301-30

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