NDC 67850-042

Tranexamic Acid

Tranexamic Acid

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

Product ID67850-042_2ccb8d54-823f-42f3-9c06-25ba18b1365a
NDC67850-042
Product TypeHuman Prescription Drug
Proprietary NameTranexamic Acid
Generic NameTranexamic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-03-11
Marketing CategoryANDA / ANDA
Application NumberANDA202436
Labeler NameMethapharm, Inc.
Substance NameTRANEXAMIC ACID
Active Ingredient Strength100 mg/mL
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 67850-042-10

10 AMPULE in 1 CARTON (67850-042-10) > 10 mL in 1 AMPULE (67850-042-00)
Marketing Start Date2019-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67850-042-10 [67850004210]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA202436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-11

NDC 67850-042-00 [67850004200]

Tranexamic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA202436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-11

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID100 mg/mL

OpenFDA Data

SPL SET ID:8b113279-b4d8-490a-ad82-f8683ed13e6e
Manufacturer
UNII

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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