Tranexamic Acid

Product NDC
63323-563
11-digit product format
633230563
Labeler code
63323
Product ID
63323-563_ddb5d068-9d9e-45da-92d7-516dd792af1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091596
Marketing category
ANDA
Marketing start
2012-05-24
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-563-10ML - Milliliter63323-56305aeae2e-7d2c-4871-9cfb-10e915a86f6112013-09-04
63323-563-97ML - Milliliter63323-5635853a5b5-427a-4845-a641-b6a59a96110e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-563TRANEXAMIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Legacy NDC20220319_c6c3da51-fc45-4d5c-b983-1576830c95dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-563-106332305631010 VIAL in 1 TRAY (63323-563-10) > 10 mL in 1 VIAL (63323-563-01) 10 vial2012-05-240000-00-00NoNoCurrent