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  5. NDC Package Code: 82511-009-10 Gemcitabine Hydrochloride

NDC Package 82511-009-10 Gemcitabine Hydrochloride

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
82511-009-10
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-USE
Product Code:
82511-009
Proprietary Name:
Gemcitabine Hydrochloride
Non-Proprietary Name:
Gemcitabine Hydrochloride
Substance Name:
Gemcitabine Hydrochloride
Usage Information:
Gemcitabine for Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1)] .
11-Digit NDC Billing Format:
82511000910
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Teyro Labs Private Limited
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(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
GEMCITABINE HYDROCHLORIDE 1 g/25mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA078759
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-08-2024
Listing Expiration Date:
12-31-2026
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.

Frequently Asked Questions

What is NDC 82511-009-10?

The NDC Packaged Code 82511-009-10 is assigned to a package of 1 vial, single-use in 1 carton / 25 ml in 1 vial, single-use of Gemcitabine Hydrochloride, a human prescription drug labeled by Teyro Labs Private Limited. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Is NDC 82511-009 included in the NDC Directory?

Yes, Gemcitabine Hydrochloride with product code 82511-009 is active and included in the NDC Directory. The product was first marketed by Teyro Labs Private Limited on August 08, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 82511-009-10?

The 11-digit format is 82511000910. 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
5-3-282511-009-105-4-282511-0009-10