FDA.reportPublic FDA data

Tranexamic Acid

Product NDC
65145-106
11-digit product format
651450106
Labeler code
65145
Product ID
65145-106_32ed8990-d6ba-4d63-8caf-37d231fa8813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA212360
Marketing category
ANDA
Marketing start
2025-01-03
Substance
TRANEXAMIC ACID
Active strength
100 mg/mL
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 ACID100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui238720

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
65145-106-01Tranexamic Acid10 mL in 1 VIALINJECTION107
65145-106-10Tranexamic Acid10 in 1 BOXINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-106-01ML - Milliliter65145-1069ac24db1-dfda-4e4c-850e-13825fad352412025-11-13
65145-106-10ML - Milliliter65145-10640c1c7a8-928d-4617-8c17-2d785440f20e12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-106TRANEXAMIC ACID INJECTION [CAPLIN STERILES LIMITED]7Current NDC, Legacy NDC, 2 package rows20250105_6326bdbf-fb2e-451a-a0a0-7d0b59ce5438.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSN6326bdbf-fb2e-451a-a0a0-7d0b59ce54387
23872010 ML tranexamic acid 100 MG/ML InjectionSCD6326bdbf-fb2e-451a-a0a0-7d0b59ce54387
238720tranexamic acid 1000 MG per 10 ML InjectionSY6326bdbf-fb2e-451a-a0a0-7d0b59ce54387

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-106-016514501060110 mL in 1 VIAL10 mlHistorical
65145-106-106514501061010 VIAL in 1 BOX (65145-106-10) / 10 mL in 1 VIAL (65145-106-01) 10 vial2025-01-030000-00-00NoNoCurrent