TRANEXAMIC ACID

Product NDC
17478-217
11-digit product format
174780217
Labeler code
17478
Product ID
17478-217_96662ef9-879d-46dd-90ed-ec3e414c5dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Akorn, Inc.
Application
ANDA202373
Marketing category
ANDA
Marketing start
2015-03-09
Marketing end
0000-00-00
Substance
TRANEXAMIC ACID
Active strength
100 mg/mL
Pharmacologic classes
Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-217-10ML - Milliliter17478-217e66145dd-223c-4be5-8b13-f4e5cd0f164212015-04-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-217-101747802171010 AMPULE in 1 CARTON (17478-217-10) > 10 mL in 1 AMPULE10 ampule2015-03-090000-00-00NoNoCurrent