Ng 2% Lactose 450 98% Powder
NDC Package 46438-0109-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ng 2% Lactose 450 98% powders is a medication used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). This formulation utilizes a powder delivery system. Marketed by Dipharma Francis Srl, this product is identified by NDC 46438-0109.

Identification & Billing

NDC Package Code
46438-0109-0
Package Description
50 kg in 1 DRUM
Product Code
46438-0109
11-Digit Billing Format
46438010900

Clinical Specifications

Proprietary Name
Ng 2% Lactose 450 98%
Non-Proprietary Name
Ng 2% Lactose 450 98%
Substance Name
Nitroglycerin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
NITROGLYCERIN 1 kg/kg
Usage Information
This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

Regulatory & Marketing

Labeler Name
Dipharma Francis Srl
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-13-2005
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 46438-0109-0 identifies a specific commercial package of 50 kg in 1 drum of Ng 2% Lactose 450 98% (UNFINISHED drug), a bulk ingredient labeled by Dipharma Francis Srl. This powder is formulated for use and contains nitroglycerin 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 Dipharma Francis Srl on October 13, 2005. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

How is this Dipharma Francis Srl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46438010900. 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 (5-4-1)
46438-0109-0
11-Digit CMS (5-4-2)
46438-0109-00

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