Norepinephrine Bitartrate Injection, Solution, Concentrate
NDC Package 67457-852-04

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

Package Information

Norepinephrine Bitartrate injection is  For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-852 and is authorized under FDA application ANDA211242.

Identification & Billing

NDC Package Code
67457-852-04
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00)
Product Code
67457-852
11-Digit Billing Format
67457085204
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Norepinephrine Bitartrate
Non-Proprietary Name
Norepinephrine Bitartrate
Substance Name
Norepinephrine Bitartrate
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NOREPINEPHRINE BITARTRATE 1 mg/mL
Pharmacologic Class
Usage Information
 For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).  As an adjunct in the treatment of cardiac arrest and profound hypotension.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211242
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-15-2018
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 67457-852-04 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose (67457-852-00) of Norepinephrine Bitartrate, a human prescription drug labeled by Mylan Institutional Llc. This injection, solution, concentrate is formulated for intravenous use and contains norepinephrine bitartrate 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 Mylan Institutional Llc on October 15, 2018. The current certification is valid through December 31, 2026.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457085204. 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)
67457-852-04
11-Digit CMS (5-4-2)
67457-0852-04

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