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 38 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: 789U1901C5
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 789U1901C5
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 789U1901C5
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 789U1901C5
unii: 451W47IQ8X
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: C151H8M554
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RageACONITUM NAPELLUS, ADRENALINUM, AGARICUS MUSCARIUS, APIS MELLIFICA, ATROPINUM, CAMPHORA, CANTHARIS, CAUSTICUM, CEREBRUM SUIS, CHAMOMILLA, CICUTA VIROSA, CUPRUM METALLICUM, HOMARUS, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, LAC CANINUM, MOSCHUS, STRAMONIUM, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.5cbc13c2-9dfb-4178-b539-06c940c3f4332024-11-06WarningsExact identifier
unii: 789U1901C5
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
unii: 451W47IQ8X
CopperFixxCOPPER AND ARNICA MONTANAQuest Products, Inc.ff2d3197-a8f3-46ff-899d-670a953d41d52024-11-05WarningsExact identifier
unii: 789U1901C5
Licefreee EverydaySODIUM CHLORIDETec Laboratories,Inc.407b5fd6-2331-2ba7-e054-00144ff88e882024-11-05WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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