OXLUMO
These highlights do not include all the information needed to use OXLUMO safely and effectively. See full prescribing information for OXLUMO. OXLUMO (lumasiran) injection, for subcutaneous use Initial U.S. Approval: 2020
Approved
Approval ID
16985a31-f5e4-4557-9266-fc78d4bc5055
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
Alnylam Pharmaceuticals, Inc.
DUNS: 115524410
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lumasiran
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71336-1002
Application NumberNDA214103
Product Classification
M
Marketing Category
C73594
G
Generic Name
lumasiran
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (4)
lumasiranActive
Quantity: 94.5 mg in 0.5 mL
Code: RZT8C352O1
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT