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 8 mg Added to 0.9% Sodium Chloride 250 mL Bag

• 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 32 mcg norepinephrine base, 9.2 mg sodium chloride, 64 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. 02/15

CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

image description

NOREPINEPHRINE BITARTRATE
norepinephrine bitartrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52533-217
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV)	NOREPINEPHRINE	32 ug in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9.2 mg in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	64 ug in 1 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52533-217-18	250 mL in 1 BAG; Type 0: Not a Combination Product	02/18/2015	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/18/2015	12/06/2017

Labeler - Cantrell Drug Company (035545763)

Revised: 12/2017

Document Id: 5faf19f9-4dc5-73bd-e053-2991aa0a9773

Set id: 1093e746-cb28-4537-becb-b84670b88309

Version: 2

Effective Time: 20171206

Cantrell Drug Company