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.

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Norepinephrine Bitartrate 16 mg Added to 5% Dextrose 250 mL Bag

Label

• 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-164
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Norepinephrine Bitartrate (UNII: IFY5PE3ZRW) (Norepinephrine - UNII:X4W3ENH1CV) Norepinephrine64 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 50 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 473.6 ug  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C) 128 ug  in 1 mL
WATER (UNII: 059QF0KO0R)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-164-18250 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/12/2015
Labeler - Cantrell Drug Company (035545763)

Revised: 3/2015
Document Id: 5a29af4c-a60f-4c60-8048-5ca1a689b091
Set id: 2ba1f768-ccc7-41d0-8039-ccb81931fedd
Version: 1
Effective Time: 20150312
 
Cantrell Drug Company