DILAUDID Solution for injection Ref.[10871] Active ingredients: Hydromorphone

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.

DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 1 mg or 2 mg of hydromorphone hydrochloride.

The chemical name of DILAUDID is 4,5ฮฑ-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C17H19NO3ยทHCl, and it has the following chemical structure:

Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride.

The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.

Dosage Forms and Strengths

DILAUDID INJECTION: Each single-dose prefilled syringe contains 0.5 mg/0.5 mL, 1 mg/mL or 2 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.
How Supplied

DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless single-dose prefilled syringes. Each single-dose prefilled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows:

Product Code Unit of Sale Strength Each
771905 NDC 76045-009-05
Unit of 24 		0.5 mg/0.5 mL NDC 76045-009-03
0.5 mL single-dose prefilled syringe
771910 NDC 76045-009-10
Unit of 24 		1 mg/mL NDC 76045-009-00
1 mL single-dose prefilled syringe
771010 NDC 76045-010-10
Unit of 24 		2 mg/mL NDC 76045-010-00
1 mL single-dose prefilled syringe

Safety and Handling Instructions

Access to drugs with a potential for abuse such as DILAUDID INJECTION 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 health care providers.

Drugs

Drug Countries
DILAUDID Australia, Canada, United States
 
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