Sodium Phosphates Injection, Solution
NDC Package 80830-2310-5

11-digit billing NDC: 80830231005
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sodium Phosphates (sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, heptahydrate) injection is sodium phosphates injection, 3 mmol P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. This formulation utilizes a injection, solution delivery system. Marketed by Amneal Pharmaceuticals Private Limited, this product is identified by NDC 80830-2310 and is authorized under FDA application ANDA218274.

Identification & Billing

NDC Package Code
80830-2310-5
Package Description
25 VIAL in 1 CARTON / 15 mL in 1 VIAL (80830-2310-1)
Product Code
80830-2310
11-Digit Billing Format
80830231005

Clinical Specifications

Proprietary Name
Sodium Phosphates
Non-Proprietary Name
Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic, Heptahydrate
Substance Name
Sodium Phosphate, Monobasic, Monohydrate; Sodium Phosphate, Dibasic, Heptahydrate
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)
Usage Information
Sodium phosphates injection, 3 mmol P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-20-2026
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 80830-2310-5 identifies a specific commercial package of 25 vial in 1 carton / 15 ml in 1 vial (80830-2310-1) of Sodium Phosphates, a human prescription drug labeled by Amneal Pharmaceuticals Private Limited. This injection, solution is formulated for intravenous use and contains sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate 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 Amneal Pharmaceuticals Private Limited on October 20, 2026. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80830231005. 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 (5-4-1)
80830-2310-5
11-Digit CMS (5-4-2)
80830-2310-05

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