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  5. NDC Package Code: 69097-537-31 Testosterone Cypionate

NDC Package 69097-537-31 Testosterone Cypionate

Injection Intramuscular - 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:
69097-537-31
Package Description:
1 mL in 1 VIAL, GLASS
Product Code:
69097-537
Proprietary Name:
Testosterone Cypionate
Non-Proprietary Name:
Testosterone Cypionate
Substance Name:
Testosterone Cypionate
Usage Information:
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:
69097053731
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
1 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 2047882 - testosterone cypionate 200 MG in 1 ML Injection
  • RxCUI: 2047882 - 1 ML testosterone cypionate 200 MG/ML Injection
  • RxCUI: 2047882 - testosterone cypionate 200 MG per 1 ML Injection
  • RxCUI: 835829 - testosterone cypionate 100 MG/ML Injectable Solution
  • RxCUI: 835829 - testosterone cypionate 1000 MG per 10 ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cipla Usa Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • TESTOSTERONE CYPIONATE 200 mg/mL
    • Pharmacologic Class(es):
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androstanes - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA210362
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-15-2023
    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
    69097-537-3710 mL in 1 VIAL, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69097-537-31?

    The NDC Packaged Code 69097-537-31 is assigned to a package of 1 ml in 1 vial, glass of Testosterone Cypionate, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is injection and is administered via intramuscular form.

    Is NDC 69097-537 included in the NDC Directory?

    Yes, Testosterone Cypionate with product code 69097-537 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on September 15, 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 NDC billing unit for package 69097-537-31?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 69097-537-31?

    The 11-digit format is 69097053731. 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
    5-3-269097-537-315-4-269097-0537-31