Norepinephrine Bitartrate

NOREPINEPHRINE BITARTRATE — norepinephrine bitartrate injection, solution
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Label
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• 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 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.

Rx Only

Rev. 03/15

CANTRELL DRUG COMPANY
LITTLE ROCK, AR 72207

NOREPINEPHRINE BITARTRATE
norepinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-164
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Norepinephrine Bitartrate (Norepinephrine) Norepinephrine 64 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DEXTROSE 50 mg in 1 mL
SODIUM CHLORIDE 473.6 ug in 1 mL
SODIUM METABISULFITE 128 ug in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52533-164-18 250 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/12/2015
Labeler — Cantrell Drug Company (035545763)

Revised: 03/2015 Cantrell Drug Company

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