NDC 0053-7653 - Zemaira

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
0053-7653
Package NDCs from labels
0053-7653-20, 0053-7653-80, 0053-7653-12, 0053-7653-52, 0053-7653-07
Manufacturer
CSL Behring LLC
Effective date
2024-09-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zemaira - CSL Behring LLCCSL Behring LLC2024-09-23PLASMA DERIVATIVE
Helixate FS - CSL Behring LLC | Bayer HealthCare LLCCSL Behring LLC | Bayer HealthCare LLC2016-05-31PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0053-7653ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT ZEMAIRA (.ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]27Unmatched20240926_0c3354b5-a1d8-4f98-ad55-2eafe4265c4e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alpha-1-proteinase inhibitor humanACTIVE INGREDIENTF43I396OISZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
alpha-1-proteinase inhibitor humanACTIVE MOIETYF43I396OISZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
hydrochloric acidINACTIVE INGREDIENTQTT17582CBZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
MannitolINACTIVE INGREDIENT3OWL53L36AZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
sodium hydroxideINACTIVE INGREDIENT55X04QC32IZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
Sodium PhosphateINACTIVE INGREDIENTSE337SVY37ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]16
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE INGREDIENTP89DR4NY54HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE MOIETYP89DR4NY54HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
CALCIUMINACTIVE INGREDIENTSY7Q814VUPHELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
CHLORIDE IONINACTIVE INGREDIENTQ32ZN48698HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
COPPERINACTIVE INGREDIENT789U1901C5HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
GLYCINEINACTIVE INGREDIENTTE7660XO1CHELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
HISTIDINEINACTIVE INGREDIENT4QD397987EHELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LHELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
SUCROSEINACTIVE INGREDIENTC151H8M554HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14
TRI-N-BUTYL PHOSPHATEINACTIVE INGREDIENT95UAS8YAF5HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]14

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 43 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PMSAPIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.575b4736-5bae-4f15-b55b-3e1fbbb613ff2024-07-01WarningsExact identifier
unii: 789U1901C5
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
ColicComfortACTIVATED CHARCOAL, COPPER, CITRULLUS COLOCYNTHIS FRUITBoiron74aa5ab4-cd93-36b0-e053-2991aa0a10682024-06-11Exact identifier
unii: 789U1901C5
ParaGard T 380ACOPPERCooperSurgical, Inc.3c420b53-c95e-46af-aebd-73741be583912024-06-09Warnings, Adverse reactionsExact identifier
unii: 789U1901C5
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUMNutritional Specialties, Inc.2f4acf3d-09d7-4dcc-b23c-793b0e2d53b12024-06-05WarningsExact identifier
unii: 789U1901C5
CUPRUM METCUPRUM METRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a0ce3d2-bbcc-9d69-e063-6294a90ae3af2024-06-04WarningsExact identifier
unii: 789U1901C5
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUMNutritional Specialties, Inc.2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc2024-05-31WarningsExact identifier
unii: 789U1901C5
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
unii: 451W47IQ8X
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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