"0517-0960-10" National Drug Code (NDC)

Tranexamic Acid 10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS
(American Regent, Inc.)

NDC Code0517-0960-10
Package Description10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS
Product NDC0517-0960
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTranexamic Acid
Non-Proprietary NameTranexamic Acid
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20111115
Marketing Category NameANDA
Application NumberANDA201885
ManufacturerAmerican Regent, Inc.
Substance NameTRANEXAMIC ACID
Strength100
Strength Unitmg/mL
Pharmacy ClassesAntifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]

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