Testosterone Solution
NDC Package 62332-488-11

11-digit billing NDC: 62332048811
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Testosterone solution is testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. This formulation utilizes a solution delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-488 and is authorized under FDA application ANDA212882.

Identification & Billing

NDC Package Code
62332-488-11
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 110 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
62332-488
11-Digit Billing Format
62332048811
RxNorm Crosswalk
  • RxCUI: 1599949 - testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT
  • RxCUI: 1599949 - 60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution
  • RxCUI: 1599949 - 60 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical Solution
  • RxCUI: 1599949 - testosterone (as testosterone propionate) 2 % Topical Solution

Clinical Specifications

Proprietary Name
Testosterone
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TESTOSTERONE 30 mg/1.5mL
Pharmacologic Class
Usage Information
Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.Limitations of use:Safety and efficacy of testosterone topical solution in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.Safety and efficacy of testosterone topical solution in males <18 years old have not been established [see Use in Specific Populations (8.4)].
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212882
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62332-488-11 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 110 ml in 1 bottle, with applicator of Testosterone, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This solution is formulated for topical use and contains testosterone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alembic Pharmaceuticals Inc. on December 08, 2021. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332048811. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
62332-488-11
11-Digit CMS (5-4-2)
62332-0488-11

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.