Home NDC 68012-350-02 Ruconest
Product NDC 68012-350
Requested package NDC 68012-350-02
11-digit product format 680120350
Labeler code 68012
Product ID 68012-350_1ee71ee6-7d7a-4543-bb0f-4b463801b5e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name c1 esterase inhibitor recombinant
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Santarus, Inc.
Application BLA125495
Marketing category BLA
Marketing start 2014-09-22
Marketing end 2022-01-18
Substance CONESTAT ALFA
Active strength 2100 U/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CONESTAT ALFA ACTIVE INGREDIENT 5QS67N4551 RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.] 12 CONESTAT ALFA ACTIVE MOIETY 5QS67N4551 RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.] 12 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.] 12 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.] 12
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.
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 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68012-350-02 68012035002 1 VIAL, SINGLE-USE in 1 CARTON (68012-350-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (68012-350-01) 2014-09-22 2022-01-18 No No Current