TRANEXAMIC ACID

Product NDC
59651-839
11-digit product format
596510839
Labeler code
59651
Product ID
59651-839_773eb919-7d48-4ba2-af58-aa169f0ea75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRANEXAMIC ACID
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205133
Marketing category
ANDA
Marketing start
2023-12-04
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
59651-839-30TRANEXAMIC ACID30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-839-30EA - Each59651-8390100a7a8-c6cd-4903-9fc1-75ad4521166f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-839TRANEXAMIC ACID TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20231209_773eb919-7d48-4ba2-af58-aa169f0ea75f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN773eb919-7d48-4ba2-af58-aa169f0ea75f1
883826tranexamic acid 650 MG Oral TabletSCD773eb919-7d48-4ba2-af58-aa169f0ea75f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-839-305965108393030 TABLET in 1 BOTTLE (59651-839-30) 30 tablet2023-12-04NoNoCurrent