NDC 81284-611

tranexamic acid 100 mg per 1 mL injection, solution

On the label: Provepharm Inc..

China: 1India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Hunan Dongting Pharmaceutical Co., Ltd.ChinaMakes the active ingredient No problems foundMay 24, 2024 · 3 inspections
Immacule Lifesciences Private LimitedSolan, IndiaMakes it, tests it, packages it and labels it Serious problems, FDA actionSep 18, 2025 · 3 inspections, 1 with FDA action
Analytical SolutionsNavi Mumbai, IndiaTests it Problems found, fixed voluntarilyNov 28, 2025 · 6 inspections

Product details

Generic drug
Tranexamic Acid: every company that makes it
Form
injection, solution, intravenous
Strength
100 mg per 1 mL
Approval
ANDA ANDA212676
On the market since
Sep 30, 2021
Package NDCs
81284-611-00 81284-611-10
Official label
DailyMed (National Library of Medicine), updated Aug 12, 2025

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