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.

----------

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, MedNet

image description

• 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 30 mL (30 mg) of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride in a 30 mL Single-Dose PCA Vial.

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:52533-006-05 30 mL in 1 VIAL, PATENT DELIVERY SYSTEM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/30/2011
Labeler - Cantrell Drug Company (035545763)

Revised: 3/2015
Document Id: 369bab03-2a77-463e-bb0f-45d35d838bfc
Set id: 467c62b6-8ec1-4b72-8987-c32b8a3400a6
Version: 18
Effective Time: 20150323
 
Cantrell Drug Company