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 64 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationfbc01464-8885-4075-af41-911ffec5ae922020-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ParaGard T 380ACOPPERCooperSurgical, Inc.5ea7ce51-b87a-485e-b841-99466a07a4b22019-09-09Warnings, Adverse reactionsExact identifier
unii: 789U1901C5
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Kids ReliefPULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFINALIS, SABADILLA, ARALIA RACEMOSA, CUPRUM METALLICUMHomeolab International (Canada) inc7978fb75-fac9-480d-830c-c8c09ff29be12019-07-25WarningsExact identifier
unii: 789U1901C5
Kids ReliefPULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFINALIS, SABADILLA, STICTA PULMONARIA, ARAILA RACEMOSA, CUPRUM METALLICUMHomeolab International (Canada) incba120c26-1e84-48b9-b38a-df5aa75ea6ce2019-07-16WarningsExact identifier
unii: 789U1901C5
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: 451W47IQ8X
Leg Cramps ReliefCUPRIC ARSENITE, COPPER, POTASSIUM PHOSPHATE, DIBASIC, LACTIC ACID, L-,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATEHomeocare Laboratoriese34601fb-2bd8-498a-9910-d82410e930362018-12-31WarningsExact identifier
unii: 789U1901C5
Muscular Pain ReliefARNICA MONTANA, COPPER, POTASSIUM PHOSPHATE, DIBASIC, LACTIC ACID, DL-,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHomeocare Laboratories7ef95005-8cd2-4d7d-af73-4d3dd47128db2018-12-26WarningsExact identifier
unii: 789U1901C5
PMS ReliefCOPPER, ESTRONE, HISTAMINE DIHYDROCHLORIDE, MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE, SODIUM SULFATEHomeocare Laboratories70821f51-c62b-411b-9469-6e7da82948d62018-12-26WarningsExact identifier
unii: 789U1901C5
GUNA-SINUS NOSEALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -Guna spa36fef678-17c6-4d2a-a0f0-ddb298611f252018-12-22WarningsExact identifier
unii: 789U1901C5
H.M.D.ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOMZorex International8c53091a-904d-4756-93e4-17143c5b48e92018-12-21WarningsExact identifier
unii: 789U1901C5
unii: 451W47IQ8X
GUNA-RHINO NOSEAPIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -Guna spa5baeb698-1735-4586-9984-2a2cb0da871a2018-12-21WarningsExact identifier
unii: 789U1901C5
Vitality FemaleARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIANatural Creations, Inc679ba86d-bf84-4ded-b0bf-d55a0df9faa42018-12-21WarningsExact identifier
unii: 451W47IQ8X
Nausea CPAETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc2746cde1-577b-41d6-9f22-93d8f1a2c2352018-12-21WarningsExact identifier
unii: 789U1901C5
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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