Tranexamic Acid

Product NDC
69918-301
11-digit product format
699180301
Labeler code
69918
Product ID
69918-301_7bafece1-f0b8-4852-92ca-fe2bf261be04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Nordic Pharma, Inc.
Application
NDA022430
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-03-01
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
69918-301-30Tranexamic Acid30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-301-30EA - Each69918-301cd1935aa-ac46-4848-a837-555cd61acaab12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-301TRANEXAMIC ACID TABLET [AMRING PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20221223_031bf7c2-3b07-469d-bc5a-31fc6238e25f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
883826tranexamic acid 650 MG Oral TabletPSN031bf7c2-3b07-469d-bc5a-31fc6238e25f7
883826tranexamic acid 650 MG Oral TabletSCD031bf7c2-3b07-469d-bc5a-31fc6238e25f7
883826tranexamic acid 650 MG Oral TabletPSNe8cdb0d6-9498-2902-e053-2995a90a9de43
883826tranexamic acid 650 MG Oral TabletSCDe8cdb0d6-9498-2902-e053-2995a90a9de43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69918-301-306991803013030 TABLET in 1 BOTTLE (69918-301-30) 30 tablet2016-03-010000-00-00NoNoCurrent