FDA.reportPublic FDA data

Tranexamic Acid in Sodium Chloride

Product NDC
66298-5340
11-digit product format
662985340
Labeler code
66298
Product ID
66298-5340_2bafe5a8-0ec4-b2c9-e063-6294a90a2d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRANEXAMIC ACID
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HP Halden Pharma AS
Application
ANDA218242
Marketing category
ANDA
Marketing start
2024-12-10
Substance
TRANEXAMIC ACID
Active strength
10 mg/mL
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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui2170286

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66298-5340-1Tranexamic Acid in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION1001
66298-5340-1Tranexamic Acid in Sodium Chloride24 in 1 CASEINJECTION, SOLUTION241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66298-5340TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [HP HALDEN PHARMA AS]1Current NDC, 2 package rows20250116_0c638812-ba60-49fe-a715-f40246b6cbf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170286tranexamic acid 1000 MG in 100 ML InjectionPSN0c638812-ba60-49fe-a715-f40246b6cbf71
2170286100 ML tranexamic acid 10 MG/ML InjectionSCD0c638812-ba60-49fe-a715-f40246b6cbf71
2170286tranexamic acid 1000 MG in 100 ML InjectionSY0c638812-ba60-49fe-a715-f40246b6cbf71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66298-5340-16629853400124 BAG in 1 CASE (66298-5340-1) / 100 mL in 1 BAG24 bag2024-12-10NoNoCurrent