Venofer Injection, Solution
NDC Package 0517-2340-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Venofer (iron sucrose) injection is this medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. This formulation utilizes a injection, solution delivery system. Marketed by American Regent, Inc., this product is identified by NDC 0517-2340 and is authorized under FDA application NDA021135.

Identification & Billing

NDC Package Code
0517-2340-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
0517-2340
11-Digit Billing Format
00517234001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Venofer
Non-Proprietary Name
Iron Sucrose
Substance Name
Iron Sucrose
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
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. You may need extra iron because of blood loss during kidney dialysis. Your body may also need more iron if you use the drug erythropoietin to help make new red blood cells. Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many patients with kidney disease cannot get enough iron from food and require injections.

Regulatory & Marketing

Labeler Name
American Regent, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021135
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-14-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1756
Source: PDAC
INJECTION, IRON SUCROSE, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0517-2340). Click a package code to view its specific billing and regulatory data.

0517-2340-10
10 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
0517-2340-25
25 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE
0517-2340-99
10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0517-2340-01 identifies a specific commercial package of 1 vial, single-dose in 1 box / 5 ml in 1 vial, single-dose of Venofer, a human prescription drug labeled by American Regent, Inc.. This injection, solution is formulated for intravenous use and contains iron sucrose as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by American Regent, Inc. on July 14, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. You may need extra iron because of blood loss during kidney dialysis. Your body may also need more iron if you use the drug erythropoietin to help make new red blood cells. Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many patients with kidney disease cannot get enough iron from food and require injections.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517234001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0517-2340-01
11-Digit CMS (5-4-2)
00517-2340-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.