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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
| 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 | BLA125495 |
Purple Book Biologic Products#
| 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 | 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 |