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 18 of 54 · 1,065 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Com-Pare2 Dual Yeast Relief Plus Multi-symptom FormulaCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHURTRP Company42b6b9b9-a673-0bba-e063-6394a90a88662025-11-03WarningsExact identifier
unii: 451W47IQ8X
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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