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Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.
VIAL LABELS
Vial Label 30 mg/10 mL
Vial Label 30 mg
Vial Label 90 mg
CARTONS
Unit Carton 30 mg/10 mL
Unit Carton 30 mg
Unit Carton 90 mg
PAMIDRONATE DISODIUM
pamidronate disodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55390-604
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMIDRONATE DISODIUM (PAMIDRONIC ACID) PAMIDRONATE DISODIUM 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 47 mg in 1 mL
PHOSPHORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55390-604-01 1 in 1 BOX, UNIT-DOSE
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021113 03/28/2002 09/30/2010
PAMIDRONATE DISODIUM
pamidronate disodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55390-157
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMIDRONATE DISODIUM (PAMIDRONIC ACID) PAMIDRONATE DISODIUM 30 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 470 mg in 10 mL
PHOSPHORIC ACID
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55390-157-01 1 in 1 BOX, UNIT-DOSE
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075290 06/12/2002 08/31/2012
PAMIDRONATE DISODIUM
pamidronate disodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55390-159
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMIDRONATE DISODIUM (PAMIDRONIC ACID) PAMIDRONATE DISODIUM 90 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 375 mg in 10 mL
PHOSPHORIC ACID
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55390-159-01 1 in 1 BOX, UNIT-DOSE
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075290 06/