Sodium Bicarbonate Injection, Solution
NDC Package 70095-050-03

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 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 Sun Pharmaceutical Industries Limited, this product is identified by NDC 70095-050 and is authorized under FDA application ANDA217594.

Identification & Billing

NDC Package Code
70095-050-03
Package Description
25 VIAL in 1 CARTON / 50 mL in 1 VIAL (70095-050-01)
Product Code
70095-050
11-Digit Billing Format
70095005003
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 84 mg/mL
Pharmacologic Class
Alkalinizing Activity - [MoA] (Mechanism of Action)
Usage Information
Sodium Bicarbonate Injection 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  CO2  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
Sun Pharmaceutical Industries Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217594
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-15-2024
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70095-050-03 identifies a specific commercial package of 25 vial in 1 carton / 50 ml in 1 vial (70095-050-01) of Sodium Bicarbonate, a human prescription drug labeled by Sun Pharmaceutical Industries Limited. 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 Sun Pharmaceutical Industries Limited on March 15, 2024. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70095005003. 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)
70095-050-03
11-Digit CMS (5-4-2)
70095-0050-03

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