Carmustine (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 70121-1668-1

Carmustine for Injection USP, 100 mg/vial

Rx Only

Vial Label

Amneal Biosciences LLC

NDC 70121-3639-1

Sterile Diluent (Dehydrated Alcohol Injection, USP), 3 mL

Rx Only

Vial Label

Amneal Biosciences LLC

NDC 70121-1482-2

Carmustine for Injection USP, 100 mg/vial

Rx Only

Carton Label

Amneal Biosciences LLC

CARMUSTINE carmustine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1482

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-1482-2 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 3 mL Part 2 1 VIAL, SINGLE-DOSE 30 mL

Part 1 of 2 DEHYDRATED ALCOHOL alcohol injection

Product Information Item Code (Source) NDC:70121-3639 Route of Administration INTRAVENOUS DEA Schedule

Inactive Ingredients Ingredient Name Strength ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-3639-1 3 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211229 10/22/2018

Part 2 of 2 CARMUSTINE carmustine injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:70121-1668 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARMUSTINE (CARMUSTINE) CARMUSTINE 100 mg in 30 mL

Product Characteristics Color YELLOW (PALE YELLOW) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70121-1668-1 30 mL in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211229 10/22/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211229 10/22/2018

Labeler — Amneal Pharmaceuticals LLC (827748190)

Revised: 12/2019 Amneal Pharmaceuticals LLC