Ruconest
These highlights do not include all the information needed to use RUCONEST safely and effectively. See full prescribing information for RUCONEST. RUCONEST (C1 esterase inhibitor [recombinant]) For Intravenous Use, Lyophilized Powder For Reconstitution Initial U.S. Approval: 2014
Approved
Approval ID
66d3fecb-32a4-7781-e053-2a91aa0a83ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Pharming Healthcare Inc.
DUNS: 073255908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
c1 esterase inhibitor recombinant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71274-350
Application NumberBLA125495
Product Classification
M
Marketing Category
C73585
G
Generic Name
c1 esterase inhibitor recombinant
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (4)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CONESTAT ALFAActive
Quantity: 2100 U in 1 1
Code: 5QS67N4551
Classification: ACTIB