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  5. NDC Package Code: 70985-021-02 Oxybutynin Chloride Extended Release

NDC Package 70985-021-02 Oxybutynin Chloride Extended Release

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70985-021-02
Package Description:
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
70985-021
Proprietary Name:
Oxybutynin Chloride Extended Release
Non-Proprietary Name:
Oxybutynin Chloride
Substance Name:
Oxybutynin Chloride
Usage Information:
Oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination. Oxybutynin belongs to a class of drugs known as antispasmodics. The manufacturer does not recommend using this medication in children younger than 5 years of age.
11-Digit NDC Billing Format:
70985002102
NDC to RxNorm Crosswalk:
  • RxCUI: 863636 - oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863636 - 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet
  • RxCUI: 863636 - oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Drug Ocean Llc
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OXYBUTYNIN CHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA206121
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-05-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70985-021-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70985-021-02?

    The NDC Packaged Code 70985-021-02 is assigned to a package of 500 tablet, extended release in 1 bottle of Oxybutynin Chloride Extended Release, a human prescription drug labeled by Drug Ocean Llc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 70985-021 included in the NDC Directory?

    Yes, Oxybutynin Chloride Extended Release with product code 70985-021 is active and included in the NDC Directory. The product was first marketed by Drug Ocean Llc on October 05, 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 70985-021-02?

    The 11-digit format is 70985002102. 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
    5-3-270985-021-025-4-270985-0021-02