FDA.reportPublic FDA data

NDC 72485-510-01 - 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
72485-510
Requested NDC
72485-510-01
Package NDCs from labels
72485-510-01, 72485-510-10
Manufacturer
Armas Pharmaceuticals Inc. | Caplin Steriles Limited
Effective date
2024-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tranexamic Acid - Armas Pharmaceuticals Inc. | Caplin Steriles LimitedArmas Pharmaceuticals Inc. | Caplin Steriles Limited2024-02-06Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-510-01Tranexamic Acid10 mL in 1 VIALINJECTION101
72485-510-10Tranexamic Acid10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-510TRANEXAMIC ACID INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240214_a3468b9f-a1c1-43ca-afc0-5b32c8f58b83.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-510-01ML - Milliliter72485-510e0e8dfaa-1408-428e-9daf-0d57586a646e12024-04-05
72485-510-10ML - Milliliter72485-51035e49398-d006-4041-b921-6c937e63e62b12024-04-05

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 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
tranexamic acidTRANEXAMIC ACIDAvenacy, Inc.00630e54-0e84-465d-96a5-63486c87dcd92024-03-15Warnings, Adverse reactionsExact identifier
rxcui: 238720
unii: 6T84R30KC1
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Tranexamic AcidTRANEXAMIC ACIDArmas Pharmaceuticals Inc.a3468b9f-a1c1-43ca-afc0-5b32c8f58b832024-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA212360
ndc (package): 72485-510-10
ndc (package): 72485-510-01
ndc (product): 72485-510
ndc11 (package): 72485051001
rxcui: 238720
spl id: a3468b9f-a1c1-43ca-afc0-5b32c8f58b83
spl set id: a3468b9f-a1c1-43ca-afc0-5b32c8f58b83
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

Reported adverse events (FAERS/openFDA)#

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