Ifosfamide
These highlights do not include all the information needed to use IFOSFAMIDE INJECTION safely and effectively. See full prescribing information for IFOSFAMIDE INJECTION. IFOSFAMIDE injection, intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
c90ab05f-8fe5-437e-a1c0-8b11ef63291e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ifosfamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9531
Application NumberANDA076619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ifosfamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (4)
IFOSFAMIDEActive
Quantity: 50 mg in 1 mL
Code: UM20QQM95Y
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.035 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 3.55 mg in 1 mL
Code: GR686LBA74
Classification: IACT
Ifosfamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9530
Application NumberANDA076619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ifosfamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (4)
IFOSFAMIDEActive
Quantity: 50 mg in 1 mL
Code: UM20QQM95Y
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.035 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 3.55 mg in 1 mL
Code: GR686LBA74
Classification: IACT