NDC 0591-3720

Tranexamic Acid

Tranexamic Acid

Tranexamic Acid is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Tranexamic Acid.

Product ID0591-3720_4b4c3dfb-827a-44d6-9e01-7836a0c28453
NDC0591-3720
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA202093
Labeler NameActavis Pharma, Inc.
Substance NameTRANEXAMIC ACID
Active Ingredient Strength650 mg/1
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-3720-10

1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-10)
Marketing Start Date2013-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3720-30 [00591372030]

Tranexamic Acid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202093
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-03

NDC 0591-3720-10 [00591372010]

Tranexamic Acid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202093
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-03

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID650 mg/1

OpenFDA Data

SPL SET ID:3f07e93b-3568-487e-894f-8f90e5a0960a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 883826
  • 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

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