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  5. NDC Package Code: 0517-0610-01 Injectafer

NDC Package 0517-0610-01 Injectafer

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
0517-0610-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0517-0610
Proprietary Name:
Injectafer
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:
00517061001
Labeler Name:
American Regent, Inc.
Sample Package:
No
FDA Application Number:
NDA203565
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
01-01-2023
End Marketing Date:
05-10-2021
Listing Expiration Date:
05-10-2021
Exclude Flag:
D
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 0517-0610-01?

The NDC Packaged Code 0517-0610-01 is assigned to a package of 1 vial, single-dose in 1 box / 10 ml in 1 vial, single-dose of Injectafer, labeled by American Regent, Inc.. The product's dosage form is and is administered via form.

Is NDC 0517-0610 included in the NDC Directory?

No, Injectafer with product code 0517-0610 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by American Regent, Inc. on January 01, 2023 and its listing in the NDC Directory is set to expire on May 10, 2021 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0517-0610-01?

The 11-digit format is 00517061001. 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
4-4-20517-0610-015-4-200517-0610-01