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

1
(click image for full-size original)

NDC 70121-3639-1

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

Rx Only

Vial Label

Amneal Biosciences LLC

b
(click image for full-size original)

NDC 70121-1482-2

Carmustine for Injection USP, 100 mg/vial

Rx Only

Carton Label

Amneal Biosciences LLC

o
(click image for full-size original)

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

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