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Hydromorphone Injection: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule II Boxed warning Current since November 3, 2026
Strength:
2 mg/mL, 0.5 mg/0.5 mL, 1 mg/mL, 0.2 mg/mL
Brand names:
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Hydromorphone Injection

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging and Prefilled Syringe

NOTES:

  • Do not introduce any other fluid into the syringe at any time.
  • Do not dilute for IV push.
  • Do not re-sterilize the syringe.
  • Do not use this product on a sterile field.
  • This product is for single dose only.
  1. 1. Once removed from the bundle, inspect the outer packaging by verifying:
  • Integrity of the tube and the cap.
  • Tamper evident seal is intact.

Do not use if the outer packaging has been damaged.

  1. 2. Hold the outer packaging with both hands. To break the tamper evident seal, hold the tube and the cap close to the seal, and twist until broken. (See Figure 2)

Figure 2

  1. 3. Remove the cap of the outer packaging by pulling it straight away from the tube.
  2. 4. Remove the syringe from the tube.
  3. 5. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  4. 6. Push plunger rod slightly to break the stopper loose while tip cap is still on.
  5. 7. Twist off the syringe tip cap. (See Figure 3)

Figure 3

  1. 8. Expel air bubble(s). Adjust the dose (if applicable).
  2. 9. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
  3. 10. Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Hikma Pharmaceuticals USA Inc. at 1-877-845-0689.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 216899 · View the label on DailyMed

Revision date stated in the text: July 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Hydromorphone Injection

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IISchedule II: high potential for abuse; abuse may lead to severe psychological or physical dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Opioid Agonist
Active ingredient Hydromorphone hydrochloride
Dosage form Injection
Route Intramuscular, Intravenous, Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) HIKMA
FDA approval ANDA 216899Abbreviated New Drug Application (ANDA) – generic drug Approved February 9, 2024
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 5 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Packages (NDC)
Package
2 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 0641-6170-01
0.5 mg/0.5 mL – 0.5 ml in 1 syringe / 10 in 1 carton NDC 0641-6206-01
1 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 0641-6169-01
0.2 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 0641-6259-01

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.