Cyclophosphamide
CYCLOPHOSPHAMIDE Tablets USP, 25 mg and 50 mg
Approved
Approval ID
15d30249-4714-4b13-b8ca-5dff38424282
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5218
Application NumberANDA040032
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2012
FDA Product Classification
INGREDIENTS (6)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CYCLOPHOSPHAMIDEActive
Quantity: 25 mg in 1 1
Code: 8N3DW7272P
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Cyclophosphamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5005
Application NumberANDA040032
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclophosphamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2012
FDA Product Classification
INGREDIENTS (6)
CYCLOPHOSPHAMIDEActive
Quantity: 50 mg in 1 1
Code: 8N3DW7272P
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT