Sulfamethoxazole and Trimethoprim (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mL Container Label

5 mL Container Label

Carton Label (10 X 5 mL Single-Dose Vials)

Carton Label

10 mL Container Label

10 mL Container Label

Carton Label (10 X 10 mL Multiple-Dose Vials)

Carton Label (10 X 10 mL Single-Dose Vials)

30 mL Container Label

30 mL Container Label

Carton Label (30 mL Multiple-Dose Vial)

Carton Label (30 mL Multiple-Dose Vial)

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-361 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE 80 mg in 1 mL TRIMETHOPRIM (TRIMETHOPRIM) TRIMETHOPRIM 16 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL DIETHANOLAMINE ALCOHOL PROPYLENE GLYCOL SODIUM METABISULFITE WATER

Product Characteristics Color YELLOW (Clear, colorless to pale yellow solution) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-361-10 10 VIAL in 1 CARTON contains a VIAL (70069-361-01) 1 NDC:70069-361-01 5 mL in 1 VIAL This package is contained within the CARTON (70069-361-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212231 08/29/2019

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-362 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE 80 mg in 1 mL TRIMETHOPRIM (TRIMETHOPRIM) TRIMETHOPRIM 16 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL DIETHANOLAMINE ALCOHOL PROPYLENE GLYCOL SODIUM METABISULFITE WATER

Product Characteristics Color YELLOW (Clear, colorless to pale yellow solution) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-362-10 10 VIAL in 1 CARTON contains a VIAL (70069-362-01) 1 NDC:70069-362-01 10 mL in 1 VIAL This package is contained within the CARTON (70069-362-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212231 08/29/2019

SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole and trimethoprim injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-363 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE 80 mg in 1 mL TRIMETHOPRIM (TRIMETHOPRIM) TRIMETHOPRIM 16 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL DIETHANOLAMINE ALCOHOL PROPYLENE GLYCOL SODIUM METABISULFITE WATER

Product Characteristics Color YELLOW (Clear, colorless to pale yellow solution) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-363-01 1 VIAL in 1 CARTON contains a VIAL 1 30 mL in 1 VIAL This package is contained within the CARTON (70069-363-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212231 08/29/2019

Labeler — Somerset Therapeutics, LLC (079947873)

Registrant — Somerset Therapeutics, LLC (079947873)

Establishment
Name	Address	ID/FEI	Operations
Somerset Therapeutics Limited		677236695	ANALYSIS (70069-361), ANALYSIS (70069-362), ANALYSIS (70069-363), LABEL (70069-361), LABEL (70069-362), LABEL (70069-363), PACK (70069-361), PACK (70069-362), PACK (70069-363), MANUFACTURE (70069-361), MANUFACTURE (70069-362), MANUFACTURE (70069-363)

Revised: 05/2022 Somerset Therapeutics, LLC