Cyclophosphamide (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC: 70121–1238–1

Cyclophosphamide for Injection USP, 500 mg/Vial

Rx Only

Amneal Pharmaceuticals LLC

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vb
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NDC: 70121–1239–1

Cyclophosphamide for Injection USP, 1 g/Vial

Rx Only

Amneal Pharmaceuticals LLC

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kl
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NDC: 70121–1240–1

Cyclophosphamide for Injection USP, 2 g/Vial

Rx Only

Amneal Pharmaceuticals LLC

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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: 08/2023 Amneal Pharmaceuticals LLC

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