• Warnings And Precautions
Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.
Norepinephrine Bitartrate
FDA Label NDC 52533-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cantrell Drug Company for the product Norepinephrine Bitartrate (NDC 52533-164). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding • warnings and precautions, • adverse events, • how supplied, • ingredients, • storage and handling, • dosage and administration., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
• Adverse Events
To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.
• How Supplied
Norepinephrine bitartrate injection solution is supplied as a sterile, nonpyrogenic solution that is clear, colorless at 250 mL in a Single-Dose Injection Solution Bag.
This product is Preservative-Free and Latex-Free.
• Ingredients
Each 1 mL contains the equivalent of 64 mcg norepinephrine base, 50 mg dextrose, 473.6 mcg sodium chloride, 128 mcg sodium metabisulfite, and pH adjusters include hydrochloric acid and/or sodium hydroxide, if necessary.
• Storage And Handling
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
• Dosage And Administration.
FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.
* Please review the disclaimer below.
