TRANEXAMIC ACID

Product NDC
71335-2695
11-digit product format
713352695
Labeler code
71335
Product ID
71335-2695_c616ecfa-42f7-49a2-898f-5aee4405c607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRANEXAMIC ACID
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA218320
Marketing category
ANDA
Marketing start
2024-06-11
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
71335-2695-1TRANEXAMIC ACID8 in 1 BOTTLETABLET81
71335-2695-2TRANEXAMIC ACID30 in 1 BOTTLETABLET301
71335-2695-3TRANEXAMIC ACID4 in 1 BOTTLETABLET41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN5b0c13fe-2c8e-4ac8-8bda-140881bd0cc41
883826tranexamic acid 650 MG Oral TabletSCD5b0c13fe-2c8e-4ac8-8bda-140881bd0cc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2695-1713352695018 TABLET in 1 BOTTLE (71335-2695-1) 8 tablet2025-09-24NoNoHistorical
71335-2695-27133526950230 TABLET in 1 BOTTLE (71335-2695-2) 30 tablet2025-09-24NoNoHistorical
71335-2695-3713352695034 TABLET in 1 BOTTLE (71335-2695-3) 4 tablet2025-09-24NoNoHistorical