Onpattro
These highlights do not include all the information needed to use ONPATTRO safely and effectively. See full prescribing information for ONPATTRO. ONPATTRO (patisiran) lipid complex injection, for intravenous useInitial U.S. Approval: 2018
Approved
Approval ID
e87ec36f-b4b4-49d4-aea4-d4ffb09b0970
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 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.
patisiran
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71336-1000
Application NumberNDA210922
Product Classification
M
Marketing Category
C73594
G
Generic Name
patisiran
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (9)
MC-3Inactive
Quantity: 13 mg in 1 mL
Code: Q0J6FQ6FKP
Classification: IACT
1,2-DIMYRISTOYL-SN-GLYCERO-3-CARBOXAMINOPROPYLPOLYETHYLENE GLYCOL 2000 METHYL ETHERInactive
Quantity: 1.6 mg in 1 mL
Code: G739VUB5KO
Classification: IACT
patisiran sodiumActive
Quantity: 2 mg in 1 mL
Code: WO0YM16LKG
Classification: ACTIM
1,2-Distearoyl-sn-glycero-3-phosphocholineInactive
Quantity: 3.3 mg in 1 mL
Code: 043IPI2M0K
Classification: IACT
Sodium ChlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4J9FJ0HL51
Classification: IACT
Sodium phosphate, dibasic, heptahydrateInactive
Quantity: 2.3 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
CholesterolInactive
Quantity: 6.2 mg in 1 mL
Code: 97C5T2UQ7J
Classification: IACT