NDC 63833-765 - HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human)

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
63833-765
Package NDCs from labels
63833-765-18, 63833-765-19, 63833-765-15, 63833-765-53, 63833-765-54, 63833-765-55
Manufacturer
CSL Behring GmbH
Effective date
2022-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) - CSL Behring GmbHCSL Behring GmbH2022-02-04PLASMA DERIVATIVE
Berinert - CSL Behring GmbHCSL Behring GmbH2021-09-21PLASMA DERIVATIVE
Humate-P - CSL Behring GmbHCSL Behring GmbH2020-08-17PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63833-765BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]33Unmatched20210928_8ea0c7fe-da9d-4218-a080-0509e09bedc6.zip
63833-765HUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]16Unmatched20200826_c5f4b63b-8d8b-45b3-b530-2f1c32a1b852.zip
63833-765HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN) (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]8Unmatched20220831_e270ad38-adc4-4ed5-88e3-943b93d20a57.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN C1-ESTERASE INHIBITORACTIVE INGREDIENT6KIC4BB60GBERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]20
HUMAN C1-ESTERASE INHIBITORACTIVE MOIETY6KIC4BB60GBERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]20
GlycineINACTIVE INGREDIENTTE7660XO1CBERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]20
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]20
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH]20
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE INGREDIENT5T6B772R4QHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE MOIETY5T6B772R4QHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
albumin (human)INACTIVE INGREDIENTZIF514RVZRHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
GlycineINACTIVE INGREDIENTTE7660XO1CHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8
WaterINACTIVE INGREDIENT059QF0KO0RHUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]8

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 41 of 54 · 1,065 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
unii: TE7660XO1C
Isolyte S pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATEB. Braun Medical Inc.150437b6-320e-4c69-a434-2a26a1f0b2e42023-10-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, 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.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 451W47IQ8X
Epiforce P-HPARSENICUM ALBUM, BORAX, GRAPHITES, NATRUM MURIATICUM, SEPIA, SULPHURBioActive Nutritional, Inc.250441d1-e261-417e-9100-700368ea38fd2023-09-11WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.a9910e09-5aea-4ee1-a35e-ae4abf8b80b42023-09-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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