NOREPINEPHRINE BITARTRATE injection, solution

Norepinephrine Bitartrate by

Drug Labeling and Warnings

Norepinephrine Bitartrate by is a Prescription medication manufactured, distributed, or labeled by Cantrell Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

WARNINGS AND PRECAUTIONS

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

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 16 mcg norepinephrine base, 50 mg dextrose, 118.4 mcg sodium chloride, 32 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.

SPL UNCLASSIFIED SECTION

Rx Only

Rev. 03/15

CANTRELL DRUG COMPANY
LITTLE ROCK, AR 72207

INGREDIENTS AND APPEARANCE

NOREPINEPHRINE BITARTRATE 
norepinephrine bitartrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52533-165
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Norepinephrine Bitartrate (UNII: IFY5PE3ZRW) (Norepinephrine - UNII:X4W3ENH1CV)	Norepinephrine	16 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)	50 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	118.4 ug  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	32 ug  in 1 mL
WATER (UNII: 059QF0KO0R)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52533-165-18	250 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/06/2015

Labeler - Cantrell Drug Company (035545763)