NDC 14539-653-10 Oxybutynin Chloride

Oxybutynin Chloride

NDC Package Code 14539-653-10

The NDC Code 14539-653-10 is assigned to a package of 1000 tablet in 1 bottle, plastic of Oxybutynin Chloride, a human prescription drug labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 14539-653-10 is $0.07144 and is up-to-date as of 07-28-2021.

Field Name Field Value
NDC Code 14539-653-10
Package Description 1000 TABLET in 1 BOTTLE, PLASTIC
Proprietary Name Oxybutynin Chloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Oxybutynin Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses 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 14539065310 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk863664 - RxCUI What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • OXYBUTYNIN CHLORIDE 5 mg/1
Pharmacological Class(es)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANDA211682 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 06-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 14539 - Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
    • 14539-653 - Oxybutynin Chloride
      • 14539-653-10 - 1000 TABLET in 1 BOTTLE, PLASTIC

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.

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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name Field Value
Price per Unit $0.07144
Effective Date 07-21-2021 Effective Date
The effective date of the NADAC Per Unit cost.
Pricing Unit EA Pricing Unit
Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code Code 1: The NADAC was calculated using information from the most recently completed pharmacy survey. Explanation Code
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting G - Generic Classification for Rate Setting
Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
As of Date 07-28-2021
View Pricing Details

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Other Product Packages

The following packages are also available for Oxybutynin Chloride with product NDC 14539-653.

NDC Package CodePackage Description
14539-653-01100 TABLET in 1 BOTTLE, PLASTIC
14539-653-05500 TABLET in 1 BOTTLE, PLASTIC

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