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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-2634
Application NumberANDA078591
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateMay 6, 2025
FDA Product Classification

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

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Hydromorphone Hydrochloride - FDA Drug Approval Details