Cosela Injection, Powder, Lyophilized, For Solution
NDC Package 73462-101-01

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

Package Information

Cosela (trilaciclib) injection is cOSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by G1 Therapeutics, Inc., this product is identified by NDC 73462-101 and is authorized under FDA application NDA214200.

Identification & Billing

NDC Package Code
73462-101-01
Package Description
1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS
Product Code
73462-101
11-Digit Billing Format
73462010101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cosela
Non-Proprietary Name
Trilaciclib
Substance Name
Trilaciclib Dihydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TRILACICLIB DIHYDROCHLORIDE 300 mg/20mL
Pharmacologic Class
Usage Information
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

Regulatory & Marketing

Labeler Name
G1 Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214200
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-12-2021
End Marketing Date
12-31-2028
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 73462-101-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 20 ml in 1 vial, glass of Cosela, a human prescription drug labeled by G1 Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains trilaciclib dihydrochloride 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 G1 Therapeutics, Inc. on February 12, 2021.

How is this G1 Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73462010101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
73462-101-01
11-Digit CMS (5-4-2)
73462-0101-01

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