Dextrose Injection, Solution
NDC Package 63323-624-61

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

Package Information

Dextrose (dextrose monohydrate) injection is intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-624 and is authorized under FDA application ANDA207449.

Identification & Billing

NDC Package Code
63323-624-61
Package Description
50 BAG in 1 CASE / 100 mL in 1 BAG (63323-624-06)
Product Code
63323-624
11-Digit Billing Format
63323062461
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
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 50 mg/mL
Usage Information
Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207449
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-21-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-624). Click a package code to view its specific billing and regulatory data.

63323-624-10
10 BAG in 1 CASE / 1000 mL in 1 BAG (63323-624-03)
63323-624-50
60 BAG in 1 CASE / 50 mL in 1 BAG (63323-624-05)
63323-624-74
30 BAG in 1 CASE / 250 mL in 1 BAG (63323-624-04)
63323-624-75
20 BAG in 1 CASE / 500 mL in 1 BAG (63323-624-07)

* 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 63323-624-61 identifies a specific commercial package of 50 bag in 1 case / 100 ml in 1 bag (63323-624-06) of Dextrose, a human prescription drug labeled by Fresenius Kabi Usa, Llc. 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 Fresenius Kabi Usa, Llc on October 21, 2016. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323062461. 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)
63323-624-61
11-Digit CMS (5-4-2)
63323-0624-61

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