Sulfamethoxazole and Trimethoprim (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mL Container Label

5 mL Container Label
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5 mL Container Label

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

Carton Label (10 x 5 mL Single-Dose Vials)
(click image for full-size original)

Carton Label

10 mL Container Label

10 mL Container Label
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10 mL Container Label

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

Carton Label (10 X 10 mL Single-Dose Vials)
(click image for full-size original)

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

30 mL Container Label

30 mL Container Label
(click image for full-size original)

30 mL Container Label

Carton Label (30 mL Multiple-Dose Vial)

Carton Label (30 mL Multiple-Dose Vial)
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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

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