Sodium Nitrite Injection, Solution
NDC Package 60267-311-10

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

Package Information

Sodium Nitrite injection is an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. This formulation utilizes a injection, solution delivery system. Marketed by Hope Pharmaceuticals, this product is identified by NDC 60267-311 and is authorized under FDA application NDA203922.

Identification & Billing

NDC Package Code
60267-311-10
Package Description
10 mL in 1 VIAL, SINGLE-USE
Product Code
60267-311
11-Digit Billing Format
60267031110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Nitrite
Non-Proprietary Name
Sodium Nitrite
Substance Name
Sodium Nitrite
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 NITRITE 30 mg/mL
Usage Information
Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

Regulatory & Marketing

Labeler Name
Hope Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA203922
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-14-2012
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 60267-311-10 identifies a specific commercial package of 10 ml in 1 vial, single-use of Sodium Nitrite, a human prescription drug labeled by Hope Pharmaceuticals. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This injection, solution is formulated for intravenous use and contains sodium nitrite 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 Hope Pharmaceuticals on February 14, 2012. The current certification is valid through December 31, 2026.

How is this Hope Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60267031110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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)
60267-311-10
11-Digit CMS (5-4-2)
60267-0311-10

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