NDC 71336-1001

GIVLAARI

Givosiran Sodium

GIVLAARI is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Alnylam Pharmaceuticals, Inc.. The primary component is Givosiran Sodium.

• Product ID: 71336-1001_2f6b809a-ebc3-4cbf-b0a1-cae91e538696
• NDC: 71336-1001
• Product Type: Human Prescription Drug
• Proprietary Name: GIVLAARI
• Generic Name: Givosiran Sodium
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-12-12
• Marketing Category: NDA / NDA
• Application Number: NDA212194
• Labeler Name: Alnylam Pharmaceuticals, Inc.
• Substance Name: GIVOSIRAN SODIUM
• Active Ingredient Strength: 189 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71336-1001-1

1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-12-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71336-1001-1 [71336100101]

GIVLAARI INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA212194
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-12

Drug Details

Active Ingredients

Ingredient	Strength
GIVOSIRAN SODIUM	189 mg/mL