Tlando Capsule, Liquid Filled
NDC Package 74676-0112-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tlando (testosterone undecanoate) capsules is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Verity Pharmaceuticals Inc., this product is identified by NDC 74676-0112 and is authorized under FDA application NDA208088.

Identification & Billing

NDC Package Code
74676-0112-2
Package Description
120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Product Code
74676-0112
11-Digit Billing Format
74676011202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tlando
Non-Proprietary Name
Testosterone Undecanoate
Substance Name
Testosterone Undecanoate
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TESTOSTERONE UNDECANOATE 112.5 mg/1
Pharmacologic Class
Usage Information
This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Verity Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208088
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-15-2022
Listing Expiration
12-31-2027
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 74676-0112-2 identifies a specific commercial package of 120 capsule, liquid filled in 1 bottle, plastic of Tlando, a human prescription drug labeled by Verity Pharmaceuticals Inc.. This capsule, liquid filled is formulated for oral use and contains testosterone undecanoate 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 Verity Pharmaceuticals Inc. on April 15, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74676011202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. 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 (5-4-1)
74676-0112-2
11-Digit CMS (5-4-2)
74676-0112-02

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