Phytonadione Injection, Emulsion
NDC Package 65145-151-10

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 Caplin Steriles Limited, this product is identified by NDC 65145-151 and is authorized under FDA application ANDA219212.

Identification & Billing

NDC Package Code
65145-151-10
Package Description
2 TRAY in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01)
Product Code
65145-151
11-Digit Billing Format
65145015110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Caplin Steriles Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219212
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-26-2025
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 65145-151-10 identifies a specific commercial package of 2 tray in 1 carton / 5 vial, single-dose in 1 tray (65145-151-05) / 1 ml in 1 vial, single-dose (65145-151-01) of Phytonadione, a human prescription drug labeled by Caplin Steriles 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 Caplin Steriles Limited on April 26, 2025. 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 Caplin Steriles Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65145015110. 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 (5-3-2)
65145-151-10
11-Digit CMS (5-4-2)
65145-0151-10

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