Hydromorphone Hydrochloride
These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION. HYDROMORPHONE HYDROCHLORIDE injection, for intravenous, intramuscular, or subcutaneous use, CII Initial U.S. Approval: 1984
Approved
Approval ID
f9ca2ef5-46d8-475a-a26e-f7c8becd6db7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 5
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 Code0409-1380
Application NumberNDA200403
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 4 mg in 1 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM LACTATEInactive
Quantity: 8.93 mg in 1 mL
Code: TU7HW0W0QT
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.40 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.24 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
HYDROMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1312
Application NumberNDA200403
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM LACTATEInactive
Quantity: 8.93 mg in 1 mL
Code: TU7HW0W0QT
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.40 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.24 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-4264
Application NumberNDA200403
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 0.5 mg in 0.5 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 2.70 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM LACTATEInactive
Quantity: 4.47 mg in 0.5 mL
Code: TU7HW0W0QT
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.12 mg in 0.5 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1283
Application NumberNDA200403
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM LACTATEInactive
Quantity: 8.93 mg in 1 mL
Code: TU7HW0W0QT
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.40 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.24 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROMORPHONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1805
Application NumberNDA200403
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROMORPHONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 2.70 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 0.25 mg in 0.5 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM LACTATEInactive
Quantity: 4.47 mg in 0.5 mL
Code: TU7HW0W0QT
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 0.12 mg in 0.5 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT