Tranexamic Acid

Product NDC
71335-1981
11-digit product format
713351981
Labeler code
71335
Product ID
71335-1981_6f970956-0abd-4d4e-b3e0-3c296a401970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203256
Marketing category
ANDA
Marketing start
2021-07-01
Substance
TRANEXAMIC ACID
Active strength
650 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui883826

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1981-1Tranexamic Acid8 in 1 BOTTLETABLET8106
71335-1981-2Tranexamic Acid30 in 1 BOTTLETABLET30106
71335-1981-3Tranexamic Acid4 in 1 BOTTLETABLET4106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1981TRANEXAMIC ACID TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20240809_af95be04-a6ea-4789-8e79-7dcad332c640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSNaf95be04-a6ea-4789-8e79-7dcad332c640106
883826tranexamic acid 650 MG Oral TabletSCDaf95be04-a6ea-4789-8e79-7dcad332c640106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1981-1713351981018 TABLET in 1 BOTTLE (71335-1981-1) 8 tablet2021-10-220000-00-00NoNoCurrent
71335-1981-27133519810230 TABLET in 1 BOTTLE (71335-1981-2) 30 tablet2024-05-310000-00-00NoNoCurrent
71335-1981-3713351981034 TABLET in 1 BOTTLE (71335-1981-3) 4 tablet2022-09-27NoNoCurrent