Dextrose Monohydrate Injection, Solution
NDC Package 76329-3302-1

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

Package Information

Dextrose Monohydrate injection is 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.    The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. This formulation utilizes a injection, solution delivery system. Marketed by International Medication Systems, Limited, this product is identified by NDC 76329-3302 and is authorized under FDA application ANDA203451.

Identification & Billing

NDC Package Code
76329-3302-1
Package Description
1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE
Product Code
76329-3302
11-Digit Billing Format
76329330201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dextrose Monohydrate
Non-Proprietary Name
Dextrose Monohydrate
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 25 g/50mL
Usage Information
50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.    The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.

Regulatory & Marketing

Labeler Name
International Medication Systems, Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203451
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2021
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

A4216
Source: PDAC
STERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
HCPCS Dosage 10 ML
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 76329-3302-1 identifies a specific commercial package of 1 syringe in 1 carton / 50 ml in 1 syringe of Dextrose Monohydrate, a human prescription drug labeled by International Medication Systems, Limited. 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 International Medication Systems, Limited on November 11, 2021. The current certification is valid through December 31, 2026.

How is this International Medication Systems, Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76329330201. 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 (5-4-1)
76329-3302-1
11-Digit CMS (5-4-2)
76329-3302-01

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