"65219-646-05" National Drug Code (NDC)

Protamine Sulfate 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)
(Fresenius Kabi USA, LLC)

NDC Code65219-646-05
Package Description25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)
Product NDC65219-646
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameProtamine Sulfate
Non-Proprietary NameProtamine Sulfate
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20250328
Marketing Category NameANDA
Application NumberANDA089454
ManufacturerFresenius Kabi USA, LLC
Substance NamePROTAMINE SULFATE
Strength10
Strength Unitmg/mL
Pharmacy ClassesHeparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]

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