vial
Shelf Carton 50 mg in 2 mL
Shelf Carton 100 mg in 4 mL
Shelf Carton 200 mg in 8 mL
Shelf Carton 250 mg in 10 mL
METHOTREXATE
methotrexate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-143
Route of Administration INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE (METHOTREXATE) METHOTREXATE 1 g in 20 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:55390-143-01 1 VIAL ( VIAL) in 1 BOX contains a VIAL
1 20 mL in 1 VIAL This package is contained within the BOX (55390-143-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040632 09/06/2005
METHOTREXATE
methotrexate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-031
Route of Administration INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE (METHOTREXATE) METHOTREXATE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORIDE 4.9 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55390-031-10 10 VIAL ( VIAL) in 1 BOX, UNIT-DOSE contains a VIAL
1 2 mL in 1 VIAL This package is contained within the BOX, UNIT-DOSE (55390-031-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089340 05/01/1996
METHOTREXATE
methotrexate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-032
Route of Administration INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE (METHOTREXATE) METHOTREXATE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORIDE 4.9 mg in 1 mL
Product Characteristics
Color Score
Shape