FDA.reportPublic FDA data

conestat alfa 2100 UNT Injection

RxCUI
1599836
RxNorm name
conestat alfa 2100 UNT Injection
Display name
conestat alfa 2100 UNT Injection
Full name
conestat alfa 2100 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125495RuconestC1 Esterase Inhibitor (Recombinant)351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RuconestC1 ESTERASE INHIBITOR RECOMBINANTPharming Healthcare Inc.66d3fecb-32a4-7781-e053-2a91aa0a83ca2020-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1599836

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
66d3fecb-32a4-7781-e053-2a91aa0a83caconestat alfa 2100 UNT InjectionSY3These highlights do not include all the information needed to use RUCONEST ® safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant]) For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 201420200430
66d3fecb-32a4-7781-e053-2a91aa0a83caC1 esterase inhibitor (recombinant) 2100 UNT InjectionPSN3These highlights do not include all the information needed to use RUCONEST ® safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant]) For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 201420200430
66d3fecb-32a4-7781-e053-2a91aa0a83caC1 esterase inhibitor (recombinant) 2100 UNT InjectionSCD3These highlights do not include all the information needed to use RUCONEST ® safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant]) For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 201420200430