FDA.reportPublic FDA data

NDC 65145-106-01 - 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
65145-106
Requested NDC
65145-106-01
Package NDCs from labels
65145-106-01, 65145-106-10
Manufacturer
Caplin Steriles Limited
Effective date
2025-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tranexamic Acid - Caplin Steriles LimitedCaplin Steriles Limited2025-01-03Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-106-01Tranexamic Acid10 mL in 1 VIALINJECTION107
65145-106-10Tranexamic Acid10 in 1 BOXINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-106TRANEXAMIC ACID INJECTION [CAPLIN STERILES LIMITED]7Current NDC, Legacy NDC, 2 package rows20250105_6326bdbf-fb2e-451a-a0a0-7d0b59ce5438.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-106-01ML - Milliliter65145-1069ac24db1-dfda-4e4c-850e-13825fad352412025-11-13
65145-106-10ML - Milliliter65145-10640c1c7a8-928d-4617-8c17-2d785440f20e12025-11-13

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 8 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranexamic AcidTRANEXAMIC ACIDArmas Pharmaceuticals Inc.a3468b9f-a1c1-43ca-afc0-5b32c8f58b832024-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA212360
rxcui: 238720
unii: 6T84R30KC1
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACIDTRANEXAMIC ACIDHF Acquisition Co LLC, DBA HealthFirstc53e2b38-6c49-acae-e053-2995a90ae9df2024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDBryant Ranch Prepack128c39ce-f625-47ec-9efe-4de696e5220f2024-01-15Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACIDTRANEXAMIC ACIDAurobindo Pharma Limited773eb919-7d48-4ba2-af58-aa169f0ea75f2023-12-07Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDAmneal Pharmaceuticals Private Limitedc1a38ece-2050-42ea-b9de-cae3e416c59d2023-11-30Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
Tranexamic AcidTRANEXAMIC ACIDBryant Ranch Prepack4ddba10f-705a-40af-83b8-aa1fd68891f82023-11-06Warnings, Adverse reactionsExact identifier
unii: 6T84R30KC1
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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