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  5. NDC Package Code: 0615-8220-39 Oxybutynin

NDC Package 0615-8220-39 Oxybutynin

Tablet, Film Coated, Extended Release 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:
0615-8220-39
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
0615-8220
Proprietary Name:
Oxybutynin
Non-Proprietary Name:
Oxybutynin
Substance Name:
Oxybutynin Chloride
Usage Information:
Oxybutynin is used to treat an overactive bladder. By relaxing the muscles in the bladder, oxybutynin improves symptoms such as the inability to control urination (incontinence), feeling that one has to urinate (urgency), and having to go to the bathroom often (frequency). This medication belongs to the class of drugs known as antispasmodics. This medication is not recommended for use in children younger than 5 years of age. Consult your doctor for more information. Unless otherwise directed by your doctor, the over-the-counter product should only be used by adult women who have symptoms of overactive bladder for at least 2 months. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
11-Digit NDC Billing Format:
00615822039
NDC to RxNorm Crosswalk:
  • RxCUI: 863619 - oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863619 - 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet
  • RxCUI: 863619 - oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ncs Healthcare Of Ky, Llc Dba Vangard Labs
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OXYBUTYNIN CHLORIDE 10 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:
    ANDA202332
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-10-2017
    Listing Expiration Date:
    12-31-2025
    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 0615-8220-39?

    The NDC Packaged Code 0615-8220-39 is assigned to a package of 30 tablet, film coated, extended release in 1 blister pack of Oxybutynin, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0615-8220 included in the NDC Directory?

    Yes, Oxybutynin with product code 0615-8220 is active and included in the NDC Directory. The product was first marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on August 10, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0615-8220-39?

    The 11-digit format is 00615822039. 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 4-4-2 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
    4-4-20615-8220-395-4-200615-8220-39