Cisplatin Injection, Solution
NDC Package 68083-162-01

11-digit billing NDC: 68083016201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cisplatin injection is indicated as therapy to be employed as follows:Metastatic Testicular TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.Metastatic Ovarian TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-162 and is authorized under FDA application ANDA207323.

Identification & Billing

NDC Package Code
68083-162-01
Package Description
1 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
68083-162
11-Digit Billing Format
68083016201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cisplatin
Non-Proprietary Name
Cisplatin
Substance Name
Cisplatin
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CISPLATIN 1 mg/mL
Pharmacologic Class
Usage Information
Cisplatin Injection is indicated as therapy to be employed as follows:Metastatic Testicular TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.Metastatic Ovarian TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy.Advanced Bladder CancerCisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207323
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-03-2017
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 68083-162-01 identifies a specific commercial package of 1 vial in 1 carton / 50 ml in 1 vial of Cisplatin, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intravenous use and contains cisplatin 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 Gland Pharma Limited on April 03, 2017. The current certification is valid through December 31, 2027.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083016201. 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)
68083-162-01
11-Digit CMS (5-4-2)
68083-0162-01

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