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  5. NDC Package Code: 80513-101-01 Docusate Sodium, Extra Strength 250 Mg

NDC Package 80513-101-01 Docusate Sodium, Extra Strength 250 Mg

Docusate Sodium Capsule, Gelatin Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80513-101-01
Package Description:
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code:
80513-101
Proprietary Name:
Docusate Sodium, Extra Strength 250 Mg
Non-Proprietary Name:
Docusate Sodium
Substance Name:
Docusate Sodium
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.
11-Digit NDC Billing Format:
80513010101
NDC to RxNorm Crosswalk:
  • RxCUI: 1245468 - docusate sodium 250 MG Oral Capsule
  • RxCUI: 1245468 - DOSS Sodium 250 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Advanced Rx Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DOCUSATE SODIUM 250 mg/1
    • Sample Package:
    No
    FDA Application Number:
    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:
    05-25-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 80513-101-01?

    The NDC Packaged Code 80513-101-01 is assigned to a 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. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 80513-101 included in the NDC Directory?

    Yes, Docusate Sodium, Extra Strength 250 Mg with product code 80513-101 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Llc on May 25, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80513-101-01?

    The 11-digit format is 80513010101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-280513-101-015-4-280513-0101-01