FDA.reportPublic FDA data

TRANEXAMIC ACID IN SODIUM CHLORIDE

Product NDC
65219-534
11-digit product format
652190534
Labeler code
65219
Product ID
65219-534_63b55787-c021-4399-b16f-a445eaeb8e5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tranexamic acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA218242
Marketing category
ANDA
Marketing start
2024-12-01
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
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-534-01TRANEXAMIC ACID IN SODIUM CHLORIDE100 mL in 1 BAGINJECTION, SOLUTION1003
65219-534-10TRANEXAMIC ACID IN SODIUM CHLORIDE24 in 1 CASEINJECTION, SOLUTION243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-534-01ML - Milliliter65219-53435302628-b018-4eea-a292-b958ae81617e12025-03-04
65219-534-10ML - Milliliter65219-5349524ea41-0f4f-4c74-b520-39b8a5c6822712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-534TRANEXAMIC ACID IN SODIUM CHLORIDE (TRANEXAMIC ACID) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, 2 package rows20241215_63f6c65f-b06b-4905-8ff8-3ac87569c7e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2170286tranexamic acid 1000 MG in 100 ML InjectionPSN63f6c65f-b06b-4905-8ff8-3ac87569c7e03
2170286100 ML tranexamic acid 10 MG/ML InjectionSCD63f6c65f-b06b-4905-8ff8-3ac87569c7e03
2170286tranexamic acid 1000 MG in 100 ML InjectionSY63f6c65f-b06b-4905-8ff8-3ac87569c7e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-534-0165219053401100 mL in 1 BAG100 mlHistorical
65219-534-106521905341024 BAG in 1 CASE (65219-534-10) / 100 mL in 1 BAG (65219-534-01) 24 bag2024-12-01NoNoCurrent