Home NDC 70383-350 Ruconest
Product NDC 70383-350
11-digit product format 703830350
Labeler code 70383
Product ID 70383-350_9571e368-a712-5a57-e053-2a95a90a6293
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name c1 esterase inhibitor recombinant
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Bioconnection B.V.
Application BLA125495
Marketing category BLA
Marketing start 2014-09-22
Marketing end 0000-00-00
Substance CONESTAT ALFA
Active strength 2100 U/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ruconest C1 ESTERASE INHIBITOR RECOMBINANT Pharming Healthcare Inc. 66d3fecb-32a4-7781-e053-2a91aa0a83ca 2020-04-30 Warnings, Adverse reactions Exact identifier application number: BLA125495
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 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70383-350-02 70383035002 1 VIAL, SINGLE-USE in 1 CARTON (70383-350-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE 2014-09-22 0000-00-00 No No Current