Onpattro

Manufacturing Establishments (2)

Labeler

Alnylam Pharmaceuticals, Inc.

DUNS Number

080889930

Labeler

Alnylam Pharmaceuticals, Inc.

DUNS Number

023050730

NDC Product Code

71336-1000

Application Number

NDA210922

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

January 19, 2023

Ingredients

MC-3Inactive

Code: Q0J6FQ6FKPClass: IACTQuantity: 13 mg in 1 mL

1,2-DIMYRISTOYL-SN-GLYCERO-3-CARBOXAMINOPROPYLPOLYETHYLENE GLYCOL 2000 METHYL ETHERInactive

Code: G739VUB5KOClass: IACTQuantity: 1.6 mg in 1 mL

Code: WO0YM16LKGClass: ACTIMQuantity: 2 mg in 1 mL

1,2-Distearoyl-sn-glycero-3-phosphocholineInactive

Code: 043IPI2M0KClass: IACTQuantity: 3.3 mg in 1 mL

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.8 mg in 1 mL

MONOBASIC POTASSIUM PHOSPHATEInactive

Code: 4J9FJ0HL51Class: IACTQuantity: 0.2 mg in 1 mL

Sodium phosphate, dibasic, heptahydrateInactive

Code: 70WT22SF4BClass: IACTQuantity: 2.3 mg in 1 mL

WaterInactive

Code: 059QF0KO0RClass: IACT

CholesterolInactive

Code: 97C5T2UQ7JClass: IACTQuantity: 6.2 mg in 1 mL