NDC 0517-0960

Tranexamic Acid

Tranexamic Acid

Tranexamic Acid is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Tranexamic Acid.

Product ID0517-0960_135282d3-feb6-4eb9-a237-7e71bb0741bb
NDC0517-0960
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA201885
Labeler NameAmerican Regent, Inc.
Substance NameTRANEXAMIC ACID
Active Ingredient Strength100 mg/mL
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0517-0960-01

1 VIAL, GLASS in 1 CARTON (0517-0960-01) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2011-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0960-01 [00517096001]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201885
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-15

NDC 0517-0960-10 [00517096010]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201885
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-15

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID100 mg/mL

OpenFDA Data

SPL SET ID:81916afc-f83a-4bba-a810-17393980e27e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238720
  • UPC Code
  • 0305170960018
  • Pharmacological Class

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

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