FDA.reportPublic FDA data

TRANEXAMIC ACID

Product NDC
72888-178
11-digit product format
728880178
Labeler code
72888
Product ID
72888-178_47c8db95-c7ce-fe8c-e063-6294a90a4317
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRANEXAMIC ACID
Dosage form
TABLET
Route
ORAL
Labeler
ADVAGEN PHARMA LIMITED
Application
ANDA218320
Marketing category
ANDA
Marketing start
2024-06-11
Substance
TRANEXAMIC ACID
Active strength
650 mg/1
Pharmacologic classes
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
72888-178-01TRANEXAMIC ACID100 in 1 BOTTLETABLET1005
72888-178-05TRANEXAMIC ACID500 in 1 BOTTLETABLET5005
72888-178-30TRANEXAMIC ACID30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-178-30EA - Each72888-178cfd165a3-0b7e-49c1-90cc-2d66eea4195112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-178TRANEXAMIC ACID TABLET [ADVAGEN PHARMA LIMITED]4Current NDC, 3 package rows20240713_0a843fa7-1266-4666-b23f-22fd313d24a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN0a843fa7-1266-4666-b23f-22fd313d24a15
883826tranexamic acid 650 MG Oral TabletSCD0a843fa7-1266-4666-b23f-22fd313d24a15
883826tranexamic acid 650 MG Oral TabletPSN416cdb61-31fb-4554-835f-a7744aa33b611
883826tranexamic acid 650 MG Oral TabletPSN5b0c13fe-2c8e-4ac8-8bda-140881bd0cc41
883826tranexamic acid 650 MG Oral TabletSCD416cdb61-31fb-4554-835f-a7744aa33b611
883826tranexamic acid 650 MG Oral TabletSCD5b0c13fe-2c8e-4ac8-8bda-140881bd0cc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-178-0172888017801100 TABLET in 1 BOTTLE (72888-178-01) 100 tablet2024-06-11NoNoCurrent
72888-178-0572888017805500 TABLET in 1 BOTTLE (72888-178-05) 500 tablet2024-06-11NoNoCurrent
72888-178-307288801783030 TABLET in 1 BOTTLE (72888-178-30) 30 tablet2024-06-11NoNoCurrent