NDC Code(s) : 68001-563-84, 68001-564-22, 68001-565-28
Packager : BluePoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CYCLOPHOSPHAMIDEcyclophosphamide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-563
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE ANHYDROUS(UNII: 6UXW23996M)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
NITROGEN(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-563-841 in 1 CARTON 20/02/2023
12.5 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212501 02/20/2023
CYCLOPHOSPHAMIDEcyclophosphamide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-564
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE ANHYDROUS(UNII: 6UXW23996M)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
NITROGEN(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-564-221 in 1 CARTON 20/02/2023
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212501 02/20/2023
CYCLOPHOSPHAMIDEcyclophosphamide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-565
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOPHOSPHAMIDE ANHYDROUS(UNII: 6UXW23996M)
(CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M) 		CYCLOPHOSPHAMIDE ANHYDROUS200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
NITROGEN(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-565-281 in 1 CARTON 20/02/2023
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212501 02/20/2023

LABELER - BluePoint Laboratories(985523874)

Establishment
Name Address ID/FEI Business Operations
Ingenus Pharmaceuticals GmbH 482730327 analysis(68001-563, 68001-564, 68001-565), manufacture(68001-563, 68001-564, 68001-565), pack(68001-563, 68001-564, 68001-565), sterilize(68001-563, 68001-564, 68001-565)

PRINCIPAL DISPLAY PANEL

Cyclophosphamide Injection, 500mg/2.5ml vial labelCyclophosphamide Injection, 500mg/2.5ml vial labelCyclophosphamide Injection, 500mg/2.5ml vial labelCyclophosphamide Injection, 500mg/2.5ml vial labelCyclophosphamide Injection, 500mg/2.5ml vial labelCyclophosphamide Injection, 500mg/2.5ml vial label