FDA.reportPublic FDA data

TRANEXAMIC ACID

Product NDC
72603-387
11-digit product format
726030387
Labeler code
72603
Product ID
72603-387_8f780336-472e-45e4-9a62-9f1b938a44af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tranexamic acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC
Application
ANDA203521
Marketing category
ANDA
Marketing start
2024-11-25
Substance
TRANEXAMIC ACID
Active strength
100 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRANEXAMIC ACID100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T84R30KC1
Rxcui238720

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
72603-387-01TRANEXAMIC ACID10 mL in 1 VIAL, SINGLE-DOSEINJECTION102
72603-387-10TRANEXAMIC ACID10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-387-01ML - Milliliter72603-387d1a12213-ffea-4ac9-b4a9-b27b1ddd3c3712025-01-14
72603-387-10ML - Milliliter72603-38708f91443-26c6-4361-9dfa-905385b67f7512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-387TRANEXAMIC ACID INJECTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20241126_faa7c6bc-d7b9-48d5-9446-542a6a376db8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238720tranexamic acid 1000 MG in 10 ML InjectionPSNfaa7c6bc-d7b9-48d5-9446-542a6a376db82
23872010 ML tranexamic acid 100 MG/ML InjectionSCDfaa7c6bc-d7b9-48d5-9446-542a6a376db82
238720tranexamic acid 1000 MG per 10 ML InjectionSYfaa7c6bc-d7b9-48d5-9446-542a6a376db82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-387-017260303870110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72603-387-107260303871010 VIAL, SINGLE-DOSE in 1 CARTON (72603-387-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-387-01) 2024-11-25NoNoCurrent