Tranexamic Acid

Product NDC
47781-601
11-digit product format
477810601
Labeler code
47781
Product ID
47781-601_4688c116-c2c8-9958-618c-e62205bfa9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranexamic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA207239
Marketing category
ANDA
Marketing start
2017-09-01
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
47781-601-22ML - Milliliter47781-601b2258cb4-204c-4323-b52e-d70868b4fb8112017-10-13
47781-601-91ML - Milliliter47781-6014adf337a-d9c5-4f72-b95e-983d3c47190b12017-10-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-601-914778106019110 VIAL, SINGLE-DOSE in 1 CARTON (47781-601-91) > 10 mL in 1 VIAL, SINGLE-DOSE (47781-601-22) 2017-09-010000-00-00NoNoCurrent