Tranexamic Acid

Product NDC
63629-8838
11-digit product format
636298838
Labeler code
63629
Product ID
63629-8838_30e26790-6561-4a6a-938c-67ce81739ba2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202093
Marketing category
ANDA
Marketing start
2013-01-03
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8838-1Tranexamic Acid30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8838-1EA - Each63629-88389823fdc2-6cb0-4bf2-9951-1a8915983c1012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8838TRANEXAMIC ACID TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240116_128c39ce-f625-47ec-9efe-4de696e5220f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN128c39ce-f625-47ec-9efe-4de696e5220f103
883826tranexamic acid 650 MG Oral TabletSCD128c39ce-f625-47ec-9efe-4de696e5220f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8838-16362988380130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-8838-1) 2021-09-100000-00-00NoNoCurrent