Tranexamic Acid

Product NDC
50268-772
11-digit product format
502680772
Labeler code
50268
Product ID
50268-772_48364f64-73b3-8c92-e063-6294a90a8b46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
NDA022430
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-09-16
Substance
TRANEXAMIC ACID
Active strength
650 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid
Listing expiration
2027-12-31

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
50268-772-11Tranexamic Acid1 in 1 BLISTER PACKTABLET13
50268-772-13Tranexamic Acid30 in 1 BOXTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-772TRANEXAMIC ACID TABLET [AVPAK]2Current NDC, Legacy NDC, 2 package rows20240110_e8cdb0d6-9498-2902-e053-2995a90a9de4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSNe8cdb0d6-9498-2902-e053-2995a90a9de43
883826tranexamic acid 650 MG Oral TabletSCDe8cdb0d6-9498-2902-e053-2995a90a9de43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-772-11502680772111 in 1 BLISTER PACKHistorical
50268-772-135026807721330 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11) 30 blister pack2022-09-160000-00-00NoNoCurrent