NDC Package 71288-116-11 Busulfan

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

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:
71288-116-11
Package Description:
8 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)
Product Code:
Proprietary Name:
Busulfan
Non-Proprietary Name:
Busulfan
Substance Name:
Busulfan
Usage Information:
Busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML).
11-Digit NDC Billing Format:
71288011611
NDC to RxNorm Crosswalk:
  • RxCUI: 253113 - busulfan 60 MG in 10 ML Injection
  • RxCUI: 253113 - 10 ML busulfan 6 MG/ML Injection
  • RxCUI: 253113 - busulfan 60 MG per 10 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Meitheal Pharmaceuticals Inc.
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA212127
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-23-2020
    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 71288-116-11?

    The NDC Packaged Code 71288-116-11 is assigned to a package of 8 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (71288-116-10) of Busulfan, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 71288-116 included in the NDC Directory?

    Yes, Busulfan with product code 71288-116 is active and included in the NDC Directory. The product was first marketed by Meitheal Pharmaceuticals Inc. on October 23, 2020 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 71288-116-11?

    The 11-digit format is 71288011611. 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
    5-3-271288-116-115-4-271288-0116-11