Docusate Sodium And Sennosides Capsule, Gelatin Coated
NDC Package 35916-0454-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Docusate Sodium And Sennosides capsules is take preferably at bedtime or as directed by a doctor.AgeStarting DosageMaximum Dosageadults and children 12 years of age and older2 softgels once a day4 softgels twice a daychildren 6 to 12 years of age1 softgel once a day2 softgels twice a daychildren under 6 years of ageask a doctorask a doctor. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Softgel Healthcare Private Limited, this product is identified by NDC 35916-0454 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
35916-0454-1
Package Description
500 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
35916-0454
11-Digit Billing Format
35916045401
RxNorm Crosswalk
  • RxCUI: 1791612 - sennosides 8.6 MG / docusate sodium 50 MG Oral Capsule
  • RxCUI: 1791612 - docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Capsule
  • RxCUI: 1791612 - DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Capsule

Clinical Specifications

Proprietary Name
Docusate Sodium And Sennosides
Non-Proprietary Name
Docusate Sodium And Sennosides
Substance Name
Docusate Sodium; Sennosides
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Take preferably at bedtime or as directed by a doctor.AgeStarting DosageMaximum Dosageadults and children 12 years of age and older2 softgels once a day4 softgels twice a daychildren 6 to 12 years of age1 softgel once a day2 softgels twice a daychildren under 6 years of ageask a doctorask a doctor

Regulatory & Marketing

Labeler Name
Softgel Healthcare Private Limited
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-22-2024
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 35916-0454-1 identifies a specific commercial package of 500 capsule, gelatin coated in 1 bottle of Docusate Sodium And Sennosides, a human over the counter drug labeled by Softgel Healthcare Private Limited. This capsule, gelatin coated is formulated for oral use and contains docusate sodium; sennosides 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 Softgel Healthcare Private Limited on June 22, 2024. The current certification is valid through December 31, 2027.

How is this Softgel Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916045401. 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)
35916-0454-1
11-Digit CMS (5-4-2)
35916-0454-01

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