Basic Information
Onpattro
71336-1000
Regulatory Information
71336-1000
NDA210922
C73594
January 19, 2023
USA
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
HUMAN PRESCRIPTION DRUG LABEL
10
Company Information
115524410
Active Ingredients
MC-3
Quantity: 13 mg in 1 mL
Code: Q0J6FQ6FKP
Class Code: IACT
1,2-DIMYRISTOYL-SN-GLYCERO-3-CARBOXAMINOPROPYLPOLYETHYLENE GLYCOL 2000 METHYL ETHER
Quantity: 1.6 mg in 1 mL
Code: G739VUB5KO
Class Code: IACT
1,2-Distearoyl-sn-glycero-3-phosphocholine
Quantity: 3.3 mg in 1 mL
Code: 043IPI2M0K
Class Code: IACT
Sodium Chloride
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Class Code: IACT
MONOBASIC POTASSIUM PHOSPHATE
Quantity: 0.2 mg in 1 mL
Code: 4J9FJ0HL51
Class Code: IACT
Sodium phosphate, dibasic, heptahydrate
Quantity: 2.3 mg in 1 mL
Code: 70WT22SF4B
Class Code: IACT
Water
Code: 059QF0KO0R
Class Code: IACT
Cholesterol
Quantity: 6.2 mg in 1 mL
Code: 97C5T2UQ7J
Class Code: IACT
Active Moieties
patisiran
Code: 50FKX8CB2Y