Phytonadione Injection, Emulsion
NDC Package 68083-606-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Phytonadione injection is vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. This formulation utilizes a injection, emulsion delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-606 and is authorized under FDA application ANDA217386.

Identification & Billing

NDC Package Code
68083-606-25
Package Description
5 TRAY in 1 CARTON / 5 AMPULE in 1 TRAY (68083-606-05) / 1 mL in 1 AMPULE
Product Code
68083-606
11-Digit Billing Format
68083060625
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phytonadione
Non-Proprietary Name
Phytonadione
Substance Name
Phytonadione
Dosage Form
Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PHYTONADIONE 10 mg/mL
Pharmacologic Class
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217386
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68083-606-25 identifies a specific commercial package of 5 tray in 1 carton / 5 ampule in 1 tray (68083-606-05) / 1 ml in 1 ampule of Phytonadione, a human prescription drug labeled by Gland Pharma Limited. This injection, emulsion is formulated for intramuscular; intravenous; subcutaneous use and contains phytonadione 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 Gland Pharma Limited on December 10, 2024. The current certification is valid through December 31, 2026.

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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083060625. 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)
68083-606-25
11-Digit CMS (5-4-2)
68083-0606-25

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