Tranexamic Acid

Product NDC

69543-376

11-digit product format

695430376

Labeler code

69543

Product ID

69543-376_978133ad-e2dc-45d2-904f-a047602c049a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Tranexamic Acid

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Virtus Pharmaceuticals, LLC

Application

ANDA202755

Marketing category

ANDA

Marketing start

2017-02-13

Marketing end

2020-08-31

Substance

TRANEXAMIC ACID

Active strength

100 mg/mL

Pharmacologic classes

Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record