Home NDC 69913-350 Ruconest
Product NDC 69913-350
11-digit product format 699130350
Labeler code 69913
Product ID 69913-350_ebd482fb-dd8a-6296-e053-2a95a90ad5e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name c1 esterase inhibitor recombinant
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Tjoapack Netherlands BV
Application BLA125495
Marketing category BLA
Marketing start 2016-09-19
Marketing end 0000-00-00
Substance CONESTAT ALFA
Active strength 2100 U/1
NDC exclude flag No
Listing certified through 2023-12-31
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 69913-350-01 69913035001 1 VIAL, SINGLE-USE in 1 CARTON (69913-350-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE 2016-09-19 0000-00-00 No No Current