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Dilaudid Injection: Uses, Side Effects and Dosage

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

Source: FDA drug labeling via NLM DailyMed · About this document

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

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging (MicroVault®) 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:

    1. - Integrity of the tube and the cap.
    2. - Tamper evident seal is intact (outer shrink wrap is not broken).

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)
  2. Figure 2
  4. 3. Remove the cap of the outer packaging by pulling it straight away from the tube to avoid dislodging the plunger rod of the syringe. (See Figure 3)
  5. Figure 3
  7. 4. Remove the syringe from the tube.
  8. 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.
  9. 6. Twist off the syringe tip cap. Do not remove the plastic wrap label around the luer lock collar. (See Figure 4)
  10. Figure 4
  12. 7. Expel air bubble(s). Adjust the dose (if applicable).
  13. 8. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
  14. 9. Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451594D

Dilaudid is a licensed trademark of Purdue Pharma L.P.

U.S. Patents 9731082, 10661018, 11426522, 10064998, 10792431, 10814059, and 11400206

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 019034 · View the label on DailyMed

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

Drug information for Dilaudid 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, solution
Route Intramuscular, Intravenous, Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval NDA 019034New Drug Application (NDA) Approved January 11, 1984
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Packages (NDC)
Package
1 mg/mL – 0.5 ml in 1 syringe / 10 in 1 carton NDC 76045-009-96
1 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 76045-009-01
2 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 76045-010-01
0.2 mg/mL – 1 ml in 1 syringe / 10 in 1 carton NDC 76045-121-01

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.