NDC 51754-0108

TRANEXAMIC ACID IN SODIUM CHLORIDE

Tranexamic Acid

TRANEXAMIC ACID IN SODIUM CHLORIDE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Exela Pharma Sciences, Llc. The primary component is Tranexamic Acid.

Product ID51754-0108_0ae0a575-08e1-43a3-9b6c-8c5f165db35f
NDC51754-0108
Product TypeHuman Prescription Drug
Proprietary NameTRANEXAMIC ACID IN SODIUM CHLORIDE
Generic NameTranexamic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-01
Marketing CategoryNDA / NDA
Application NumberNDA212020
Labeler NameExela Pharma Sciences, LLC
Substance NameTRANEXAMIC ACID
Active Ingredient Strength10 mg/mL
Pharm ClassesAntifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51754-0108-1

100 mL in 1 BAG (51754-0108-1)
Marketing Start Date2019-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51754-0108-3 [51754010803]

TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA212020
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-01

NDC 51754-0108-1 [51754010801]

TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA212020
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-01

Drug Details

Active Ingredients

IngredientStrength
TRANEXAMIC ACID10 mg/mL

Pharmacological Class

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

NDC Crossover Matching brand name "TRANEXAMIC ACID IN SODIUM CHLORIDE" or generic name "Tranexamic Acid"

NDCBrand NameGeneric Name
51754-0108TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACID IN SODIUM CHLORIDE
0013-1114Cyklokaprontranexamic acid
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
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