HEPARIN SODIUM - heparin sodium 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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Heparin Sodium 25,000 USP Units Added to 0.45% Sodium Chloride 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

Contains 25,000 USP Units of Heparin Sodium in 0.45% Sodium Chloride in a 250 mL Single-Dose Bag.  Volume & Concentration exlude additive & manufacturer overfill.

This product is Sterile, Nonpyrogenic, and Latex Free.

• INGREDIENTS

Each 1 mL contains contains Heparin Sodium 100 USP Units, Sodium Chloride 4.5 mg, Benzyl Alcohol 0.0002 mL. May contain Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment.

• STORAGE AND HANDLING

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. 

• DOSAGE AND ADMINISTRATION.

FOR INTRAVENOUS USE. 

Rx Only

Rev. 05/15

CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

HEPARIN SODIUM 
heparin sodium injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-179
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A) Heparin100 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X) 4.5 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.0002 mL  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:52533-179-18250 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/15/2015
Labeler - Cantrell Drug Company (035545763)

Revised: 5/2015
Document Id: 10f49437-e628-4575-aa90-7af9191118b9
Set id: 4882ba55-d741-4636-a3c3-866630191a65
Version: 1
Effective Time: 20150515
 
Cantrell Drug Company