FDA.reportPublic FDA data

NDC 81284-612-00 - 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
81284-612
Requested NDC
81284-612-00
Package NDCs from labels
81284-612-00, 81284-612-10
Manufacturer
Provepharm Inc. | Immacule Lifesciences Private Limited | Hunan Dongting Pharmaceutical Co., Ltd. | Analytical Solutions
Effective date
2025-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
tranexamic acidProvepharm Inc. | Immacule Lifesciences Private Limited | Hunan Dongting Pharmaceutical Co., Ltd. | Analytical Solutions2025-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81284-612-00tranexamic acid10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
81284-612-10tranexamic acid10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-612TRANEXAMIC ACID INJECTION, SOLUTION [PROVEPHARM INC.]4Current NDC, Legacy NDC, 2 package rows20240312_1b8c3500-8e87-4b6e-b6a9-8da5f9c00820.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-612-00ML - Milliliter81284-612b2a4466d-03f8-42e0-ba1e-6d17a5875a1712022-03-09
81284-612-10ML - Milliliter81284-61208e9dd4f-afad-4053-bfb4-ed670d942dcb12022-03-09

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 1 of 11 · 210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranexamic AcidTRANEXAMIC ACIDMilla Pharmaceuticals Inc.fb2fcae9-6aa0-4708-b250-b0e40beb147e2026-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212676
rxcui: 238720
unii: 6T84R30KC1
TRANEXAMIC ACIDTRANEXAMIC ACIDREMEDYREPACK INC.9d97790f-048b-494d-aa22-5689643a724b2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDApotex Corp.a93d6ef3-e160-db0d-142f-9b91af8d84282026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDEugia US LLC246a3c6c-a7fb-45c7-9509-49a48a5bdcc62026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
TRANEXAMIC ACIDTRANEXAMIC ACIDMicro Labs Limitedee5aeb09-40fb-40f9-b655-97c50652a05e2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDi3 Pharmaceuticals, LLC2c48c13a-5e7d-43ef-81a3-27d3bcda0f802026-06-29Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1

Reported adverse events (FAERS/openFDA)#

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