Home NDC 71274-350-02 Ruconest
Product NDC 71274-350
Requested package NDC 71274-350-02
11-digit product format 712740350
Labeler code 71274
Product ID 71274-350_a742815a-7705-9153-e053-2995a90a562d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name c1 esterase inhibitor recombinant
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Pharming Healthcare Inc.
Application BLA125495
Marketing category BLA
Marketing start 2018-04-01
Substance CONESTAT ALFA
Active strength 2100 U/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ruconest
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CONESTAT ALFA 2100 U/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QS67N4551 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1599836 Internal RxNorm lookup 1599841 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71274-350-01 Ruconest 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 1 3 71274-350-02 Ruconest 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71274-350 RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [PHARMING HEALTHCARE INC.] 3 Current NDC, Legacy NDC, 2 package rows 20200605_66d3fecb-32a4-7781-e053-2a91aa0a83ca.zip
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 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125495 Ruconest C1 Esterase Inhibitor (Recombinant) 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71274-350-02 71274035002 1 VIAL, SINGLE-USE in 1 CARTON (71274-350-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (71274-350-01) 2018-04-01 0000-00-00 No No Current