Cyclophosphamide
These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
Approved
Approval ID
3c1eb470-0bba-457d-94e3-b9508f0d398a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2021
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
Products 2
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 Code55150-271
Application NumberNDA210735
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (3)
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 5 mL
Code: 8N3DW7272P
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-270
Application NumberNDA210735
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (3)
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 2.5 mL
Code: 8N3DW7272P
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT