CYCLOPHOSPHAMIDE
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE for injection, for intravenous use Initial U.S. Approval: 1959
Approved
Approval ID
02e64046-687d-449e-e063-6294a90a6c32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-0260
Application NumberANDA211757
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationORAL, INTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 1500 mg in 150 mL
Code: 3OWL53L36A
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 2 g in 150 mL
Code: 8N3DW7272P
Classification: ACTIM
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-0255
Application NumberANDA211757
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 750 mg in 50 mL
Code: 3OWL53L36A
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 50 mL
Code: 8N3DW7272P
Classification: ACTIM
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-0250
Application NumberANDA211757
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 375 mg in 25 mL
Code: 3OWL53L36A
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 25 mL
Code: 8N3DW7272P
Classification: ACTIM