FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68012-35068012-350-02DDiscontinued by firm2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RuconestC1 ESTERASE INHIBITOR RECOMBINANTPharming Healthcare Inc.66d3fecb-32a4-7781-e053-2a91aa0a83ca2020-04-30Warnings, Adverse reactionsExact identifier
application number: BLA125495

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-350-01EA - Each68012-35073a23388-2e61-425d-8648-d6d118f4f65912015-01-05
68012-350-02EA - Each68012-3507140c53f-5d09-46df-9d68-e107b49b598c12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CONESTAT ALFAACTIVE INGREDIENT5QS67N4551RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.]12
CONESTAT ALFAACTIVE MOIETY5QS67N4551RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.]12
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.]12
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRRUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [SANTARUS, INC.]12

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125495RuconestC1 Esterase Inhibitor (Recombinant)351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68012-350-02680120350021 VIAL, SINGLE-USE in 1 CARTON (68012-350-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (68012-350-01) 2014-09-222022-01-18NoNoCurrent