NDC 65145-106

Tranexamic Acid

Tranexamic Acid

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

Product ID65145-106_2a487e17-1a4f-4b46-800a-068443b2d7f3
NDC65145-106
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-28
Marketing CategoryANDA / ANDA
Application NumberANDA212360
Labeler NameCaplin Steriles Limited
Substance NameTRANEXAMIC ACID
Active Ingredient Strength100 mg/mL
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65145-106-10

10 VIAL in 1 BOX (65145-106-10) > 10 mL in 1 VIAL (65145-106-01)
Marketing Start Date2021-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65145-106-01 [65145010601]

Tranexamic Acid INJECTION
Marketing CategoryANDA
Application NumberANDA212360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-28

NDC 65145-106-10 [65145010610]

Tranexamic Acid INJECTION
Marketing CategoryANDA
Application NumberANDA212360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-28

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID100 mg/mL

OpenFDA Data

SPL SET ID:6326bdbf-fb2e-451a-a0a0-7d0b59ce5438
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238720
  • UPC Code
  • 0365145106018
  • 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
    42192-605Tranexamic AcidTranexamic Acid
    42571-189Tranexamic 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
    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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