Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Vetter Pharma-Fertigung GmbH & Co. KG
Alnylam Pharmaceuticals, Inc.
344217323
Ajinomoto Althea, Inc.
Alnylam Pharmaceuticals, Inc.
023050730
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXLUMO
Product Details
NDC Product Code
71336-1002Application Number
NDA214103Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 27, 2023LumasiranActive
Code: RZT8C352O1Class: ACTIMQuantity: 94.5 mg in 0.5 mL
waterInactive
Code: 059QF0KO0RClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Phosphoric acidInactive
Code: E4GA8884NNClass: IACT