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  5. NDC Package Code: 49315-007-10 Arsenic Trioxide

NDC Package 49315-007-10 Arsenic Trioxide

Injection, 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:
49315-007-10
Package Description:
10 VIAL in 1 CARTON / 6 mL in 1 VIAL (49315-007-01)
Product Code:
49315-007
Proprietary Name:
Arsenic Trioxide
Non-Proprietary Name:
Arsenic Trioxide
Substance Name:
Arsenic Trioxide
Usage Information:
Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
11-Digit NDC Billing Format:
49315000710
NDC to RxNorm Crosswalk:
  • RxCUI: 1992545 - arsenic trioxide 12 MG in 6 ML Injection
  • RxCUI: 1992545 - 6 ML arsenic trioxide 2 MG/ML Injection
  • RxCUI: 1992545 - arsenic trioxide 12 MG per 6 ML Injection
  • RxCUI: 1992545 - arsenic trioxide 2 MG/ML per 6 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ARSENIC TRIOXIDE 2 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    ANDA206228
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-03-2019
    Listing Expiration Date:
    12-31-2024
    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 49315-007-10?

    The NDC Packaged Code 49315-007-10 is assigned to a package of 10 vial in 1 carton / 6 ml in 1 vial (49315-007-01) of Arsenic Trioxide, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 49315-007 included in the NDC Directory?

    Yes, Arsenic Trioxide with product code 49315-007 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on September 03, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 49315-007-10?

    The 11-digit format is 49315000710. 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
    5-3-249315-007-105-4-249315-0007-10