Sodium Bicarbonate Injection
NDC Package 84549-352-01

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 delivery system. Marketed by Propharma Distribution, this product is identified by NDC 84549-352 and is authorized under FDA application ANDA203449.

Identification & Billing

NDC Package Code
84549-352-01
Package Description
50 mL in 1 SYRINGE
Product Code
84549-352
11-Digit Billing Format
84549035201
RxNorm Crosswalk
  • RxCUI: 792582 - sodium bicarbonate 8.4 % (50 MEQ) in 50 ML Prefilled Syringe
  • RxCUI: 792582 - 50 ML sodium bicarbonate 84 MG/ML Prefilled Syringe
  • RxCUI: 792582 - 50 ML NaHCO3 84 MG/ML Prefilled Syringe
  • RxCUI: 792582 - sodium bicarbonate 8.4 % (50 MEQ) per 50 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Sodium Bicarbonate
Non-Proprietary Name
Sodium Bicarbonate
Substance Name
Sodium Bicarbonate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SODIUM BICARBONATE 84 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 hemoglobin and its breakdown products. 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 2content 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
Propharma Distribution
Product Type
Human Prescription Drug
FDA Application #
ANDA203449
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2000
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 84549-352-01 identifies a specific commercial package of 50 ml in 1 syringe of Sodium Bicarbonate, a human prescription drug labeled by Propharma Distribution. This injection 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 Propharma Distribution on June 01, 2000. The current certification is valid through December 31, 2026.

How is this Propharma Distribution product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84549035201. 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)
84549-352-01
11-Digit CMS (5-4-2)
84549-0352-01

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