Stool Softener And Laxative
NDC Package 68210-4180-5

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.

Stool Softener And Laxative is take preferably at bedtime or as directed by a doctorAgeStarting DosageMaximum Dosageadults & children 12 years of age & over2 tablets once a day4 tablets twice a daychildren 6 to under 12 years of age1 tablet once a day2 tablets twice a daychildren 2 to under 6 years½ tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor. Marketed by Spirit Pharmaceuticals Llc, this product is identified by NDC 68210-4180 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
68210-4180-5
Package Description
50 TABLET, FILM COATED in 1 POUCH
Product Code
68210-4180
11-Digit Billing Format
68210418005
RxNorm Crosswalk
  • RxCUI: 998740 - sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet
  • RxCUI: 998740 - docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet
  • RxCUI: 998740 - DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet

Clinical Specifications

Proprietary Name
Stool Softener And Laxative
Dosage Form
-
Usage Information
Take preferably at bedtime or as directed by a doctorAgeStarting DosageMaximum Dosageadults & children 12 years of age & over2 tablets once a day4 tablets twice a daychildren 6 to under 12 years of age1 tablet once a day2 tablets twice a daychildren 2 to under 6 years½ tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor

Regulatory & Marketing

Labeler Name
Spirit Pharmaceuticals Llc
FDA Application #
part334
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
11-22-2021
Listing Expiration
12-31-2023
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 68210-4180-5 identifies a specific commercial package of 50 tablet, film coated in 1 pouch of Stool Softener And Laxative, labeled by Spirit Pharmaceuticals 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 Spirit Pharmaceuticals Llc on November 22, 2021. The current certification is valid through December 31, 2023.

How is this Spirit Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68210418005. 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)
68210-4180-5
11-Digit CMS (5-4-2)
68210-4180-05

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