Tranexamic Acid

Product NDC
50090-4530
11-digit product format
500904530
Labeler code
50090
Product ID
50090-4530_7c84633d-aabd-4012-a600-ae678213e1d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA201580
Marketing category
ANDA
Marketing start
2012-05-18
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4530-0Tranexamic Acid10 mL in 1 VIALINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4530-0ML - Milliliter50090-45302438d600-7f65-49f6-8d3c-3d7ad4b0608012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4530TRANEXAMIC ACID INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_19f3483e-da9f-4a11-b2eb-b3c6d5d92fc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSN19f3483e-da9f-4a11-b2eb-b3c6d5d92fc84
23872010 ML tranexamic acid 100 MG/ML InjectionSCD19f3483e-da9f-4a11-b2eb-b3c6d5d92fc84
238720tranexamic acid 1000 MG per 10 ML InjectionSY19f3483e-da9f-4a11-b2eb-b3c6d5d92fc84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4530-05009045300010 mL in 1 VIAL (50090-4530-0) 10 ml2019-09-170000-00-00NoNoCurrent