Docusate Sodium Liquid
NDC Package 53807-216-08

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Docusate Sodium Liquid is follow dosing directions below or take as directed by doctormust be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritationmay be taken as a single daily dose or in divided dosestake maximum dose daily until first bowel movement, dosage should then be reduced according to individual responsedo not exceed recommended doseshake well before usingAdults and children 12 years and over1 to 4 teaspoons (50 to 200 mg)Children under 12 years of ageask a doctor 1 teaspoon = 5 mLTAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.Other informationStore at room temperature 15°-30°C (59°-86°F)protect from excessive heatKeep tightly closedDispense in tight, light resistant container as defined in the USPeach teaspoon (5 mL) contains: sodium 15 mg. Marketed by Rij Pharmaceutical Corporation, this product is identified by NDC 53807-216 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
53807-216-08
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
53807-216
11-Digit Billing Format
53807021608
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Docusate Sodium Liquid
Dosage Form
-
Usage Information
Follow dosing directions below or take as directed by doctormust be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritationmay be taken as a single daily dose or in divided dosestake maximum dose daily until first bowel movement, dosage should then be reduced according to individual responsedo not exceed recommended doseshake well before usingAdults and children 12 years and over1 to 4 teaspoons (50 to 200 mg)Children under 12 years of ageask a doctor 1 teaspoon = 5 mLTAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.Other informationStore at room temperature 15°-30°C (59°-86°F)protect from excessive heatKeep tightly closedDispense in tight, light resistant container as defined in the USPeach teaspoon (5 mL) contains: sodium 15 mg

Regulatory & Marketing

Labeler Name
Rij Pharmaceutical Corporation
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
03-16-1999
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53807-216). Click a package code to view its specific billing and regulatory data.

53807-216-16
473 mL in 1 BOTTLE, PLASTIC

* 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 53807-216-08 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Docusate Sodium Liquid, labeled by Rij Pharmaceutical Corporation. 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 Rij Pharmaceutical Corporation on March 16, 1999. The current certification is valid through December 31, 2019.

How is this Rij Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53807021608. 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)
53807-216-08
11-Digit CMS (5-4-2)
53807-0216-08

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