FDA.reportPublic FDA data

NDC 70518-4089-01 - TRANEXAMIC ACID

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70518-4089
Requested NDC
70518-4089-01
Package NDCs from labels
70518-4089-1, 70518-4089-0, 70518-4089-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRANEXAMIC ACID - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4089-0TRANEXAMIC ACID1 in 1 CARTONINJECTION12
70518-4089-0TRANEXAMIC ACID10 in 1 BOXINJECTION102
70518-4089-1TRANEXAMIC ACID10 mL in 1 VIAL, SINGLE-DOSEINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4089TRANEXAMIC ACID INJECTION [REMEDYREPACK INC.]1Current NDC, 3 package rows20240605_9d97790f-048b-494d-aa22-5689643a724b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDExela Pharma Sciences, LLCdb36ddf2-4ac5-47ac-bdce-e3fa6983073e2019-04-22Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.