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 46 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: C151H8M554
Stress EZARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, LOMATIUM DISSECTUM, COBALTUM METALLICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, IODIUM, VANADIUM METALLICUM, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOSDeseret Biologicals, Inc.4aff6989-136e-4f81-825b-3605781846c82024-03-13WarningsExact identifier
unii: 789U1901C5
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact 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.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
unii: 451W47IQ8X
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2022-2023), MORBILLINUMDeseret Biologicals, Inc.ce3962de-576a-49f6-8dc3-68ba7ad96e9f2024-03-05WarningsExact identifier
unii: 451W47IQ8X
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
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: 451W47IQ8X
Cuprum metallicumCUPRUM METALLICUMNewton Laboratories, Inc.4b348c61-01cc-641a-e063-6294a90a53e72024-03-01WarningsExact identifier
unii: 789U1901C5
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: 451W47IQ8X
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
AG-XCALCIUMAPEXEL CO., LTD.bdee5e24-645b-7fa0-e053-2995a90a7d252024-02-20WarningsExact identifier
unii: SY7Q814VUP
7030 Calcium GoldCALCIUMApexel Co., Ltdbdc7c088-83e3-20ce-e053-2995a90abd2f2024-02-20WarningsExact identifier
unii: SY7Q814VUP
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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