Cyclophosphamide
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Approved
Approval ID
14f194db-d4f1-42a7-8d10-d5cfd6465836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Long Grove Pharmaceuticals, LLC
DUNS: 081134465
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 Code81298-8110
Application NumberANDA215089
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 500 mg in 25 mL
Code: 8N3DW7272P
Classification: ACTIM
cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81298-8114
Application NumberANDA215089
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 2 g in 100 mL
Code: 8N3DW7272P
Classification: ACTIM
cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81298-8112
Application NumberANDA215089
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclophosphamide
Product Specifications
Route of AdministrationINTRAVENOUS, ORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (1)
CYCLOPHOSPHAMIDEActive
Quantity: 1 g in 50 mL
Code: 8N3DW7272P
Classification: ACTIM