Phytonadione
NDC Package 52584-043-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 inactivated by the FDA.

Phytonadione is vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. Marketed by General Injectables & Vaccines, Inc, this product is identified by NDC 52584-043 and is authorized under FDA application ANDA083722.

Identification & Billing

NDC Package Code
52584-043-05
Package Description
1 CARTON in 1 BAG / 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE
Product Code
52584-043
11-Digit Billing Format
52584004305
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phytonadione
Dosage Form
-
Usage Information
Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. These substances help your blood to thicken and stop bleeding normally (such as after an accidental cut or injury). Low levels of blood clotting factors increase the risk for unusual bleeding. Low levels may be caused by certain medications (such as warfarin) or medical conditions (such as obstructive jaundice). Vitamin K helps to treat and prevent unusual bleeding by increasing the body's production of blood clotting factors.

Regulatory & Marketing

Labeler Name
General Injectables & Vaccines, Inc
FDA Application #
ANDA083722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2013
Listing Expiration
12-31-2018
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52584-043-05 identifies a specific commercial package of 1 carton in 1 bag / 1 syringe in 1 carton / .5 ml in 1 syringe of Phytonadione, labeled by General Injectables & Vaccines, Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by General Injectables & Vaccines, Inc on February 13, 2013. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. These substances help your blood to thicken and stop bleeding normally (such as after an accidental cut or injury). Low levels of blood clotting factors increase the risk for unusual bleeding. Low levels may be caused by certain medications (such as warfarin) or medical conditions (such as obstructive jaundice). Vitamin K helps to treat and prevent unusual bleeding by increasing the body's production of blood clotting factors.

How is this General Injectables & Vaccines, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52584004305. 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 (5-3-2)
52584-043-05
11-Digit CMS (5-4-2)
52584-0043-05

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