NDC 42571-189

Tranexamic Acid

Tranexamic Acid

Tranexamic Acid is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Tranexamic Acid.

Product ID42571-189_764cdfde-2a66-0394-e053-2a91aa0ab458
NDC42571-189
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA206713
Labeler NameMicro Labs Limited
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 42571-189-57

10 CARTON in 1 CARTON (42571-189-57) > 1 AMPULE in 1 CARTON (42571-189-56) > 10 mL in 1 AMPULE
Marketing Start Date2017-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42571-189-57 [42571018957]

Tranexamic Acid INJECTION
Marketing CategoryANDA
Application NumberANDA206713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-01

NDC 42571-189-56 [42571018956]

Tranexamic Acid INJECTION
Marketing CategoryANDA
Application NumberANDA206713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-01

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID100 mg/mL

OpenFDA Data

SPL SET ID:ee5aeb09-40fb-40f9-b655-97c50652a05e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238720
  • UPC Code
  • 0342571314880
  • 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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