NDC 0009-0086-10 Depo-testosterone

Testosterone Cypionate

NDC Package Code 0009-0086-10

The NDC Code 0009-0086-10 is assigned to a package of 1 vial in 1 carton > 10 ml in 1 vial of Depo-testosterone, a human prescription drug labeled by Pharmacia And Upjohn Company Llc. The product's dosage form is injection, solution and is administered via intramuscular form.

Field Name	Field Value
NDC Code	0009-0086-10
Package Description	1 VIAL in 1 CARTON > 10 mL in 1 VIAL
Proprietary Name	Depo-testosterone 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	Testosterone Cypionate 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	This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.
11-Digit NDC Billing Format	00009008610 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	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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	Pharmacia And Upjohn Company Llc
Dosage Form	Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)	Intramuscular - Administration within a muscle.
Active Ingredient(s)	TESTOSTERONE CYPIONATE 200 mg/mL
Pharmacological Class(es)	Androgen - [EPC] (Established Pharmacologic Class) Androgen Receptor Agonists - [MoA] (Mechanism of Action) Androstanes - [CS]
DEA Schedule	Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule? The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.
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	ANDA085635 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	07-01-2014 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	12-31-2021 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

0009 - Pharmacia And Upjohn Company Llc
- 0009-0086 - Depo-testosterone
  - 0009-0086-10 - 1 VIAL in 1 CARTON

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	$6.62583
Effective Date	04-21-2021 Effective Date The effective date of the NADAC Per Unit cost.
Pricing Unit	ML 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. Code 5: The NADAC was calculated based on package size. Code 6: The CMS Covered Outpatient File drug category type of S/I/N (Single Source/Innovator/Non-Innovator) has not been applied. Most S/I drugs with the same strength, dosage form and route of administration were grouped together for the purpose of the NADAC calculation and N drugs were also grouped together. In some cases, however, in calculating a NADAC, the CMS S/I/N designation was not applied when the state Medicaid brand or generic payment practices for these drugs generally differed from the CMS Covered Outpatient File designation. 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	B-ANDA - Abbreviated New Drug Application 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).
Corresponding Generic Drug NADAC Per Unit	3.10027 Corresponding Generic Drug NADAC Per Unit The NADAC for the corresponding generic drug.
Corresponding Generic Drug Effective Date	04/21/2021 Corresponding Generic Drug Effective Date The effective date of when the Corresponding Generic Drug NADAC Per Unit is assigned to a multiple source brand drug NDC. This date may not correspond to the NADAC effective date for the generic drug due to the method by which the corresponding generic drug NADAC effective date is assigned.
As of Date	05-05-2021

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0009-0086-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00009008610	J1071	Inj testosterone cypionate	1 MG	10	1	2000	2000

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Other Product Packages

The following packages are also available for Depo-testosterone with product NDC 0009-0086.

NDC Package Code	Package Description
0009-0086-01	1 VIAL in 1 CARTON > 1 mL in 1 VIAL

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