FDA.reportPublic FDA data

NDC 0409-4346-16 - Aminocaproic 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
0409-4346
Requested NDC
0409-4346-16
Package NDCs from labels
0409-4346-16, 0409-4346-73, 0409-4346-09, 0409-4346-10
Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aminocaproic Acid - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-04-30HUMAN PRESCRIPTION DRUG LABEL
Aminocaproic Acid - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2025-12-17HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID - Henry Schein, Inc.Henry Schein, Inc.2025-07-11HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2022-12-06HUMAN PRESCRIPTION DRUG LABEL
AMINOCAPROIC ACID Injection, USPHospira, Inc.2020-01-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4346-16Aminocaproic Acid20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2020
0409-4346-73Aminocaproic Acid25 in 1 TRAYINJECTION, SOLUTION2520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4346AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]18Current NDC, Legacy NDC, 2 package rows20241210_1c5bc1dd-e9ec-44c1-9281-67ad482315d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4346-09ML - Milliliter0409-4346ae91d070-e7bc-486e-9ac8-05a8cf09bf2d12015-06-09
0409-4346-10ML - Milliliter0409-434657d92356-25bb-40de-96fb-40f23529f35c12015-05-05
0409-4346-16ML - Milliliter0409-4346a8adcb6f-ba9e-4a09-835c-5bc01879ca2712018-07-03
0409-4346-73ML - Milliliter0409-434654a48348-f511-4a27-80d1-23d3955ec53712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]11
AMINOCAPROIC ACIDACTIVE INGREDIENTU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
AMINOCAPROIC ACIDACTIVE MOIETYU6F3787206AMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAMINOCAPROIC ACID INJECTION, SOLUTION [HOSPIRA, INC.]1

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 7 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: QTT17582CB
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB
Aminocaproic AcidAMINOCAPROIC ACIDMedical Purchasing Solutions, LLC15eadaf4-5801-8044-e063-6394a90a72cf2024-04-12Warnings, Adverse reactionsExact identifier
unii: U6F3787206
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: QTT17582CB
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: QTT17582CB
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: QTT17582CB
AMINOCAPROIC ACIDAMINOCAPROIC ACIDCarnegie Pharmaceuticals, LLC0d6560a3-c67e-428e-b9b8-fab538856b412024-03-05Warnings, Adverse reactionsExact identifier
unii: U6F3787206
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: QTT17582CB
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
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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