NDC 63323-563

Tranexamic Acid

Tranexamic Acid

Tranexamic Acid 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 Tranexamic Acid.

Product ID63323-563_b2e8d0c1-8daa-4c9e-858e-ca01d3f52eaa
NDC63323-563
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA091596
Labeler NameFresenius Kabi USA, LLC
Substance NameTRANEXAMIC ACID
Active Ingredient Strength100 mg/mL
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-563-10

10 VIAL in 1 TRAY (63323-563-10) > 10 mL in 1 VIAL (63323-563-01)
Marketing Start Date2012-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-563-10 [63323056310]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-05-24

NDC 63323-563-97 [63323056397]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA202373
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-04-20
Marketing End Date2015-04-30

NDC 63323-563-01 [63323056301]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA091596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-19

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID100 mg/mL

OpenFDA Data

SPL SET ID:c6c3da51-fc45-4d5c-b983-1576830c95dd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238720
  • Pharmacological Class

    • Antifibrinolytic Agent [EPC]
    • Decreased Fibrinolysis [PE]

    NDC Crossover Matching brand name "Tranexamic Acid" or generic name "Tranexamic Acid"

    NDCBrand NameGeneric Name
    0517-0960Tranexamic Acidtranexamic acid
    0591-3720Tranexamic AcidTranexamic Acid
    14789-500Tranexamic acidTRANEXAMIC ACID
    17478-017Tranexamic AcidTranexamic Acid
    17478-018Tranexamic AcidTranexamic Acid
    17478-217TRANEXAMIC ACIDTranexamic Acid
    23155-166Tranexamic AcidTranexamic Acid
    23155-524Tranexamic AcidTranexamic Acid
    39822-1000Tranexamic AcidTranexamic Acid
    39822-1001Tranexamic AcidTranexamic Acid
    67850-041Tranexamic AcidTranexamic Acid
    68083-160Tranexamic acidTranexamic acid
    68084-929Tranexamic AcidTranexamic Acid
    68382-891Tranexamic AcidTranexamic Acid
    69543-376Tranexamic AcidTranexamic Acid
    69918-301Tranexamic AcidTranexamic Acid
    70121-1398Tranexamic AcidTranexamic Acid
    70771-1085Tranexamic AcidTranexamic Acid
    70860-400Tranexamic AcidTranexamic Acid
    42192-605Tranexamic AcidTranexamic Acid
    42571-189Tranexamic AcidTranexamic Acid
    42571-314TRANEXAMIC ACIDTRANEXAMIC ACID
    47781-601Tranexamic AcidTranexamic Acid
    55150-188Tranexamic AcidTranexamic Acid
    60505-3638Tranexamic AcidTranexamic Acid
    63323-563Tranexamic AcidTranexamic Acid
    66993-121Tranexamic AcidTranexamic Acid
    66993-090Tranexamic AcidTranexamic Acid
    67457-197Tranexamic AcidTranexamic Acid
    67850-042Tranexamic AcidTranexamic Acid
    65145-106Tranexamic AcidTranexamic Acid
    50090-4530Tranexamic AcidTranexamic Acid
    61990-0611tranexamic acidtranexamic acid
    0013-1114Cyklokaprontranexamic acid

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