FDA.reportPublic FDA data

Tranexamic Acid

Product NDC
23155-524
Requested package NDC
23155-524-41
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203521-001TRANEXAMIC ACIDTRANEXAMIC ACID100MG/MLINJECTABLE / INJECTIONAP2014-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203521-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203521-001TRANEXAMIC ACID100MG/MLINJECTABLE / INJECTIONAP2014-08-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203521-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.28ccedba-99cd-49f3-a782-798df52585242026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203521
application number: ANDA203521
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.d5f55a98-aeb8-47e1-9154-87ba702220272026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203521
application number: ANDA203521
ndc (package): 23155-524-41
ndc (product): 23155-524
ndc11 (package): 23155052441
TRANEXAMIC ACIDTRANEXAMIC ACIDNorthstar Rx LLCfaa7c6bc-d7b9-48d5-9446-542a6a376db82025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203521
application number: ANDA203521
Tranexamic AcidTRANEXAMIC ACIDEmcure Pharmaceuticals Limitedceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a2024-10-28Exact identifier
application applno (ANDA): 203521
application number: ANDA203521
tranexamic acidTRANEXAMIC ACIDAvenacy, Inc.00630e54-0e84-465d-96a5-63486c87dcd92024-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203521
application number: ANDA203521

Additional Listing Data#

Finished product
Yes
Brand name base
Tranexamic Acid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6T84R30KC1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238720Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5f55a98-aeb8-47e1-9154-87ba70222027Available on FDA.report

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
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