Tranexamic Acid

Product NDC
62559-265
11-digit product format
625590265
Labeler code
62559
Product ID
62559-265_edec7ff1-1b0a-414b-a719-e65376c7034b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA203256
Marketing category
ANDA
Marketing start
2021-07-01
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
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-265-30Tranexamic Acid30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-265TRANEXAMIC ACID TABLET [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20240424_82bc4879-bcf5-47c4-8636-a73c4e7d0de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSNaf95be04-a6ea-4789-8e79-7dcad332c640106
883826tranexamic acid 650 MG Oral TabletSCDaf95be04-a6ea-4789-8e79-7dcad332c640106
883826tranexamic acid 650 MG Oral TabletPSN82bc4879-bcf5-47c4-8636-a73c4e7d0de94
883826tranexamic acid 650 MG Oral TabletSCD82bc4879-bcf5-47c4-8636-a73c4e7d0de94
883826tranexamic acid 650 MG Oral TabletPSNcbc6f5b3-927e-4a94-8836-dbcd47ef97a83
883826tranexamic acid 650 MG Oral TabletSCDcbc6f5b3-927e-4a94-8836-dbcd47ef97a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-265-306255902653030 TABLET in 1 BOTTLE (62559-265-30) 30 tablet2021-07-010000-00-00NoNoCurrent