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  5. NDC Package Code: 68083-343-05 Cytarabine

NDC Package 68083-343-05 Cytarabine

Injection, Solution Intrathecal; Intravenous; Subcutaneous - 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:
68083-343-05
Package Description:
5 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01)
Product Code:
68083-343
Proprietary Name:
Cytarabine
Non-Proprietary Name:
Cytarabine
Substance Name:
Cytarabine
Usage Information:
Cytarabine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.
11-Digit NDC Billing Format:
68083034305
NDC to RxNorm Crosswalk:
  • RxCUI: 1731355 - cytarabine 100 MG in 5 ML Injection
  • RxCUI: 1731355 - 5 ML cytarabine 20 MG/ML Injection
  • RxCUI: 1731355 - 5 ML ara-C 20 MG/ML Injection
  • RxCUI: 1731355 - cytarabine 100 MG per 5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma 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):
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • CYTARABINE 20 mg/mL
    • Pharmacologic Class(es):
  • Nucleic Acid Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211937
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-23-2019
    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 68083-343-05?

    The NDC Packaged Code 68083-343-05 is assigned to a package of 5 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (68083-343-01) of Cytarabine, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intrathecal; intravenous; subcutaneous form.

    Is NDC 68083-343 included in the NDC Directory?

    Yes, Cytarabine with product code 68083-343 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on December 23, 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 68083-343-05?

    The 11-digit format is 68083034305. 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
    5-3-268083-343-055-4-268083-0343-05