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 66 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Diathesis V 1GINKGO BILOBA, PANCREAS (SUIS), SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, CYSTEINUM, ZINCUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, NATRUM OXALACETICUMBioActive Nutritional, Inc.58a16fcf-b05f-41a9-a580-41da6300ac7f2016-11-04WarningsExact identifier
unii: 789U1901C5
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X
64d9506f-3e9c-48f7-92b9-e9f0b069306d4e4bc43f-892a-4ca4-ad43-5383c276c61e2010-12-14Warnings, Adverse reactionsExact identifier
spl set id: 4e4bc43f-892a-4ca4-ad43-5383c276c61e
bcda2379-fca3-4e76-b8de-0d5476f929950c3354b5-a1d8-4f98-ad55-2eafe4265c4e2010-09-29Warnings, Adverse reactionsExact identifier
spl set id: 0c3354b5-a1d8-4f98-ad55-2eafe4265c4e

Reported adverse events (FAERS/openFDA)#

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