Infant Dextrose Injection, Solution
NDC Package 0404-9844-10

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

Package Information

Infant Dextrose (dextrose) injection is a medication used to treat low blood sugar levels. This formulation utilizes a injection, solution delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9844 and is authorized under FDA application NDA019445.

Identification & Billing

NDC Package Code
0404-9844-10
Package Description
1 SYRINGE in 1 BAG / 10 mL in 1 SYRINGE
Product Code
0404-9844
11-Digit Billing Format
00404984410
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Infant Dextrose
Non-Proprietary Name
Dextrose
Substance Name
Dextrose Monohydrate
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.
Active Ingredient(s)
DEXTROSE MONOHYDRATE 250 mg/mL
Usage Information
This product is used to treat low blood sugar levels. Symptoms of low blood sugar include sudden sweating, cold skin, shaking, irritability, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets, liquid, or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what to do if you miss a meal.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019445
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-10-2022
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 0404-9844-10 identifies a specific commercial package of 1 syringe in 1 bag / 10 ml in 1 syringe of Infant Dextrose, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution is formulated for intravenous use and contains dextrose monohydrate 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 Henry Schein, Inc. on January 10, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat low blood sugar levels. Symptoms of low blood sugar include sudden sweating, cold skin, shaking, irritability, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets, liquid, or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what to do if you miss a meal.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404984410. 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)
0404-9844-10
11-Digit CMS (5-4-2)
00404-9844-10

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