HYDROMORPHONE HCL - hydromorphone hydrochloride 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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Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 100 mL Bag

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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

Contains 100 mL (100 mg) of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride in a 100 mL Single-Dose Bag that is a 50 mL Prefilled Bag with 100 mL Total Volume.

This product is Sterile, Nonpyrogenic, Preservative Free, Isotonic, and Latex Free.

• INGREDIENTS

Each 1 mL contains Hydromorphone HCl 1 mg, Sodium Chloride 9 mg. 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]. Protect from freezing. Protect from Light.

• DOSAGE AND ADMINISTRATION.

FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.

Rx Only

Rev. 03/15

CANTRELL DRUG COMPANY

LITTLE ROCK, AR 72207

HYDROMORPHONE HCL 
hydromorphone hcl injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-006
Route of Administration INTRAVENOUS DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06) HYDROMORPHONE HYDROCHLORIDE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride (UNII: 451W47IQ8X) 9 mg  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:52533-006-75 100 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2015
Labeler - Cantrell Drug Company (035545763)

Revised: 3/2015
Document Id: f7a0c43e-3011-4482-b061-3bc8d92ad7ea
Set id: 6b179346-de7b-49c0-8cc0-48f5c0a26ac9
Version: 5
Effective Time: 20150330
 
Cantrell Drug Company