Cyclophosphamide (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC: 70121–1238–1

Cyclophosphamide for Injection USP, 500 mg/Vial

Rx Only

Amneal Pharmaceuticals LLC

NDC: 70121–1239–1

Cyclophosphamide for Injection USP, 1 g/Vial

Rx Only

Amneal Pharmaceuticals LLC

NDC: 70121–1240–1

Cyclophosphamide for Injection USP, 2 g/Vial

Rx Only

Amneal Pharmaceuticals LLC

CYCLOPHOSPHAMIDE cyclophosphamide injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1238 Route of Administration INTRAVENOUS, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE ANHYDROUS) CYCLOPHOSPHAMIDE ANHYDROUS 500 mg in 25 mL

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-1238-1 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 25 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70121-1238-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210046 05/31/2018

CYCLOPHOSPHAMIDE cyclophosphamide injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1239 Route of Administration INTRAVENOUS, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE ANHYDROUS) CYCLOPHOSPHAMIDE ANHYDROUS 1 g in 50 mL

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-1239-1 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 50 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70121-1239-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210046 05/31/2018

CYCLOPHOSPHAMIDE cyclophosphamide injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1240 Route of Administration INTRAVENOUS, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE ANHYDROUS) CYCLOPHOSPHAMIDE ANHYDROUS 2 g in 100 mL

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-1240-1 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 100 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70121-1240-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210046 05/31/2018

Labeler — Amneal Pharmaceuticals LLC (827748190)

Revised: 11/2019 Amneal Pharmaceuticals LLC