Tranexamic Acid

Product NDC
23155-524
11-digit product format
231550524
Labeler code
23155
Product ID
23155-524_c4a0942b-be2c-47ce-a7fc-e031804afb79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Application
ANDA203521
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
2027-12-31
Substance
TRANEXAMIC ACID
Active strength
1 g/10mL
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID1 g/10mL

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
23155-524-31Tranexamic Acid10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1013
23155-524-41Tranexamic Acid10 in 1 CARTONINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-524-31ML - Milliliter23155-52431034ce7-7ba1-449a-892c-e38c2ad5635812018-08-13
23155-524-41ML - Milliliter23155-5240efcddb9-45f5-47e8-a100-3b5e3a2cf63212018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]1
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-524TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.]12Current NDC, Legacy NDC, 2 package rows20241215_d5f55a98-aeb8-47e1-9154-87ba70222027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSNd5f55a98-aeb8-47e1-9154-87ba7022202713
23872010 ML tranexamic acid 100 MG/ML InjectionSCDd5f55a98-aeb8-47e1-9154-87ba7022202713
238720tranexamic acid 1000 MG per 10 ML InjectionSYd5f55a98-aeb8-47e1-9154-87ba7022202713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-524-312315505243110 mL in 1 VIAL, GLASS10 mlHistorical
23155-524-412315505244110 VIAL, GLASS in 1 CARTON (23155-524-41) / 10 mL in 1 VIAL, GLASS (23155-524-31) 2014-08-132027-12-31NoNoCurrent