Docusate Sodium, Extra Strength Capsule, Gelatin Coated
NDC Package 80513-101-01

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

Package Information

Docusate Sodium, Extra Strength (docusate sodium) capsules is a medication used to treat occasional constipation. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Advanced Rx Llc, this product is identified by NDC 80513-101 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
80513-101-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
80513-101
11-Digit Billing Format
80513010101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Docusate Sodium, Extra Strength 250 Mg
Non-Proprietary Name
Docusate Sodium
Substance Name
Docusate Sodium
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)
DOCUSATE SODIUM 250 mg/1
Usage Information
This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

Regulatory & Marketing

Labeler Name
Advanced Rx Llc
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-25-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80513-101-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Docusate Sodium, Extra Strength 250 Mg, a human over the counter drug labeled by Advanced Rx Llc. This capsule, gelatin coated is formulated for oral use and contains docusate sodium 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 Advanced Rx Llc on May 25, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

How is this Advanced Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80513010101. 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)
80513-101-01
11-Digit CMS (5-4-2)
80513-0101-01

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