NDC 63323-229

Protamine Sulfate

Protamine Sulfate

Protamine Sulfate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Protamine Sulfate.

Product ID63323-229_12d7e6bf-3191-4d6d-836b-1669ca3c95ec
NDC63323-229
Product TypeHuman Prescription Drug
Proprietary NameProtamine Sulfate
Generic NameProtamine Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2000-10-18
Marketing CategoryANDA / ANDA
Application NumberANDA089454
Labeler NameFresenius Kabi USA, LLC
Substance NamePROTAMINE SULFATE
Active Ingredient Strength10 mg/mL
Pharm ClassesHeparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-229-15

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21)
Marketing Start Date2000-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-229-35 [63323022935]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-94 [63323022994]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-15 [63323022915]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-21 [63323022921]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-11

NDC 63323-229-95 [63323022995]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-30 [63323022930]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-41 [63323022941]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-11

NDC 63323-229-26 [63323022926]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-18

NDC 63323-229-05 [63323022905]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-10-18

NDC 63323-229-25 [63323022925]

Protamine Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-18

Drug Details

Active Ingredients

IngredientStrength
PROTAMINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:8df0a819-9e1a-44ce-97a6-3ea82c867d44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796676
  • 1796672
  • Pharmacological Class

    • Heparin Binding Activity [MoA]
    • Heparin Reversal Agent [EPC]
    • Reversed Anticoagulation Activity [PE]

    NDC Crossover Matching brand name "Protamine Sulfate" or generic name "Protamine Sulfate"

    NDCBrand NameGeneric Name
    51662-1414PROTAMINE SULFATEPROTAMINE SULFATE
    63323-229Protamine SulfatePROTAMINE SULFATE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.