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. 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.
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
3. Remove the cap of the outer packaging by pulling it straight away from the tube.
4. Remove the syringe from the tube.
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.
6. Push plunger rod slightly to break the stopper loose while tip cap is still on.
7. Twist off the syringe tip cap. (See Figure 3)
Figure 3
8. Expel air bubble(s). Adjust the dose (if applicable).
9. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
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.
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.