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HYDROMORPHONE HYDROCHLORIDE, Vial U.S. Physician Prescribing Information (hydromorphone hydrochloride injection, USP) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Hydromorphone Hydrochloride Injection, USP (HPF) is supplied in single-dose amber vials. Each single-dose vial of sterile aqueous solution contains 10 mg per mL of hydromorphone hydrochloride, USP with 0.2% sodium citrate and 0.2% citric acid solution. Hydromorphone Hydrochloride Injection, USP (HPF) is preservative free and is supplied as follows:

Unit of Sale Concentration
*
DILUTE PRIOR TO USE. FOR USE IN THE PREPARATION OF LARGE VOLUME PARENTERAL SOLUTIONS.
NDC 0409-2634-01
Box containing 10 Single-dose vials (1 mL)
10 mg/mL
NDC 0409-2634-05
Box containing 10 Single-dose vials* (5 mL)
50 mg/5 mL (10 mg/mL)
NDC 0409-2634-50
Box containing 1 Single-dose vial* (50 mL)
500 mg/50 mL (10 mg/mL)

No added preservative.

PROTECT FROM LIGHT.

Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].

Safety and Handling Instructions

Access to drugs with a potential for abuse such as Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)] presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by healthcare providers.

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