NDC 71336-1000

Onpattro

Patisiran

Onpattro is a Intravenous Injection, Lipid Complex in the Human Prescription Drug category. It is labeled and distributed by Alnylam Pharmaceuticals, Inc.. The primary component is Patisiran Sodium.

• Product ID: 71336-1000_2d0db5c1-a61b-4e1a-bf87-534af4150b34
• NDC: 71336-1000
• Product Type: Human Prescription Drug
• Proprietary Name: Onpattro
• Generic Name: Patisiran
• Dosage Form: Injection, Lipid Complex
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-08-13
• Marketing Category: NDA / NDA
• Application Number: NDA210922
• Labeler Name: Alnylam Pharmaceuticals, Inc.
• Substance Name: PATISIRAN SODIUM
• Active Ingredient Strength: 2 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71336-1000-1

1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-08-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71336-1000-1 [71336100001]

Onpattro INJECTION, LIPID COMPLEX

• Marketing Category: NDA
• Application Number: NDA210922
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-13

Drug Details

Active Ingredients

Ingredient	Strength
PATISIRAN SODIUM	2 mg/mL

OpenFDA Data

• SPL SET ID: e87ec36f-b4b4-49d4-aea4-d4ffb09b0970
• Manufacturer:
  • Alnylam Pharmaceuticals, Inc.
• UNII:
  • WO0YM16LKG
• RxNorm Concept Unique ID - RxCUI:
  • 2053529
  • 2053524