FDA Product

Tranexamic Acid

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Tranexamic Acid

FDA Product Code

70771-1085

Regulatory Information

NDC Product Code

70771-1085

Application Number

ANDA205228

Marketing Category

C73584

Effective Date

November 5, 2022

Territorial Authority

USA

FDA Title

Tranexamic Acid Injection 100 mg/mL, 10 mL

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerZydus Lifesciences Limited

DUNS Number

918596198

Active Ingredients

TRANEXAMIC ACID

Quantity: 100 mg in 1 mL

Code: 6T84R30KC1

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

TRANEXAMIC ACID

Code: 6T84R30KC1

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