Hydromorphone Hydrochloride
These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF).HYDROMORPHONE HYDROCLORIDE injection, USP [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use Initial U.S. Approval: 1984
Approved
Approval ID
4d33b072-0755-4b8c-9558-2551306756a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-540
Application NumberANDA078228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
Effective DateJune 1, 2020
FDA Product Classification
INGREDIENTS (4)
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium Citrate, Unspecified FormInactive
Code: 1Q73Q2JULR
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydromorphone HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: L960UP2KRW
Classification: ACTIB