NDC 51662-1414

PROTAMINE SULFATE

Protamine Sulfate

PROTAMINE SULFATE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Protamine Sulfate.

Product ID51662-1414_94d4f57f-940f-c0a8-e053-2a95a90ae3af
NDC51662-1414
Product TypeHuman Prescription Drug
Proprietary NamePROTAMINE SULFATE
Generic NameProtamine Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA089454
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
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 Through2020-12-31

Packaging

NDC 51662-1414-1

5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1)
Marketing Start Date2019-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1414-1 [51662141401]

PROTAMINE SULFATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA089454
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-13

Drug Details

Active Ingredients

IngredientStrength
PROTAMINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:94d4f57f-940e-c0a8-e053-2a95a90ae3af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796672
  • UPC Code
  • 0363323229054
  • 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

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