Hydromorphone Hydrochloride
These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)] safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)]. HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use, CII Initial U.S. Approval: January 1984
Approved
Approval ID
3832ede8-d3fc-455d-ecab-3b77be5869f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2025
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydromorphone Hydrochloride
PRODUCT DETAILS
NDC Product Code0409-2634
Application NumberANDA078591
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateMay 6, 2025
Generic NameHydromorphone Hydrochloride
INGREDIENTS (3)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT