Sodium Bicarbonate Injection, Solution
NDC Package 63323-083-05

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

Package Information

Sodium Bicarbonate injection is uSP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-083 and is authorized under FDA application ANDA206688.

Identification & Billing

NDC Package Code
63323-083-05
Package Description
25 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03)
Product Code
63323-083
11-Digit Billing Format
63323008305
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Bicarbonate
Non-Proprietary Name
Sodium Bicarbonate
Substance Name
Sodium Bicarbonate
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)
SODIUM BICARBONATE 42 mg/mL
Pharmacologic Class
Alkalinizing Activity - [MoA] (Mechanism of Action)
Usage Information
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis — e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial — e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206688
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-25-2025
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 63323-083-05 identifies a specific commercial package of 25 vial, single-dose in 1 tray / 5 ml in 1 vial, single-dose (63323-083-03) of Sodium Bicarbonate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intravenous use and contains sodium bicarbonate 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 August 25, 2025. 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: 63323008305. 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)
63323-083-05
11-Digit CMS (5-4-2)
63323-0083-05

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