Tranexamic Acid

Product NDC
23155-166
11-digit product format
231550166
Labeler code
23155
Product ID
23155-166_940fb6bf-5347-4409-91b7-aec36d132a45
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
Substance
TRANEXAMIC ACID
Active strength
1 g/10mL
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
2027-12-31

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
23155-166-31Tranexamic Acid10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1020
23155-166-41Tranexamic Acid10 in 1 CARTONINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-166-31ML - Milliliter23155-166c466d9c6-9c55-453c-8bde-03df683e8d2512016-11-08
23155-166-41ML - Milliliter23155-1666c59bfa7-ec34-436e-b64b-fa24ba455e2012016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRANEXAMIC ACIDACTIVE INGREDIENT6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]3
TRANEXAMIC ACIDACTIVE MOIETY6T84R30KC1TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-166TRANEXAMIC ACID INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.]19Current NDC, Legacy NDC, 2 package rows20240210_28ccedba-99cd-49f3-a782-798df5258524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSN28ccedba-99cd-49f3-a782-798df525852421
23872010 ML tranexamic acid 100 MG/ML InjectionSCD28ccedba-99cd-49f3-a782-798df525852421
238720tranexamic acid 1000 MG per 10 ML InjectionSY28ccedba-99cd-49f3-a782-798df525852421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-166-312315501663110 mL in 1 VIAL, GLASS10 mlHistorical
23155-166-412315501664110 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31) 2014-08-130000-00-00NoNoCurrent