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  5. NDC Package Code: 49315-003-06 Clofarabine

NDC Package 49315-003-06 Clofarabine

Injection 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:
49315-003-06
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code:
49315-003
Proprietary Name:
Clofarabine
Non-Proprietary Name:
Clofarabine
Substance Name:
Clofarabine
Usage Information:
Clofarabine is used to treat a certain type of cancer (acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
49315000306
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Zydus Lifesciences Limited
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
CLOFARABINE 1 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA204029
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-10-2017
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 49315-003-06?

The NDC Packaged Code 49315-003-06 is assigned to a package of 1 vial, single-use in 1 carton / 20 ml in 1 vial, single-use of Clofarabine, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is injection and is administered via intravenous form.

Is NDC 49315-003 included in the NDC Directory?

Yes, Clofarabine with product code 49315-003 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on May 10, 2017 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 49315-003-06?

The 11-digit format is 49315000306. 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
5-3-249315-003-065-4-249315-0003-06