tranexamic acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 830016429

Effective Date

February 4, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tranexamic acid(100 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

A-S Medication Solutions

DUNS Number

830016429

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

50090-5072

Application Number

ANDA212676

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

September 11, 2020

Ingredients

Code: 6T84R30KC1Class: ACTIBQuantity: 100 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT