NDC Package 0517-0602-01 Injectafer

Ferric Carboxymaltose Injection 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:
0517-0602-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Injectafer
Non-Proprietary Name:
Ferric Carboxymaltose Injection
Substance Name:
Ferric Carboxymaltose
Usage Information:
This medication is used to treat "iron-poor" blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease. Iron is an important mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.
11-Digit NDC Billing Format:
00517060201
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1435169 - ferric carboxymaltose (as iron) 750 MG in 15 mL Injection
  • RxCUI: 1435169 - 15 ML ferric carboxymaltose 50 MG/ML Injection
  • RxCUI: 1435169 - ferric carboxymaltose (as elemental iron) 750 MG per 15 ML Injection
  • RxCUI: 1435174 - Injectafer (iron) 750 MG in 15 mL Injection
  • RxCUI: 1435174 - 15 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    American Regent, 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:
    NDA203565
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2022
    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 0517-0602-01?

    The NDC Packaged Code 0517-0602-01 is assigned to a package of 1 vial, single-dose in 1 box / 2 ml in 1 vial, single-dose of Injectafer, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0517-0602 included in the NDC Directory?

    Yes, Injectafer with product code 0517-0602 is active and included in the NDC Directory. The product was first marketed by American Regent, Inc. on June 01, 2022 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 NDC billing unit for package 0517-0602-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0517-0602-01?

    The 11-digit format is 00517060201. 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 4-4-2 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
    4-4-20517-0602-015-4-200517-0602-01