Sodium Bicarbonate Injection, Solution
NDC Package 0338-0822-10

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 contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0822 and is authorized under FDA application NDA218524.

Identification & Billing

NDC Package Code
0338-0822-10
Package Description
10 BAG in 1 CARTON / 1000 mL in 1 BAG
Product Code
0338-0822
11-Digit Billing Format
00338082210

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 12.6 mg/mL
Pharmacologic Class
Alkalinizing Activity - [MoA] (Mechanism of Action)
Usage Information
Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA218524
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-14-2026
Listing Expiration
12-31-2027
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 0338-0822-10 identifies a specific commercial package of 10 bag in 1 carton / 1000 ml in 1 bag of Sodium Bicarbonate, a human prescription drug labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on August 14, 2026. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338082210. 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)
0338-0822-10
11-Digit CMS (5-4-2)
00338-0822-10

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