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NDC 71336-1003-01 AMVUTTRA 25 mg/.5mL Details
AMVUTTRA 25 mg/.5mL
AMVUTTRA is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alnylam Pharmaceuticals, Inc.. The primary component is VUTRISIRAN.
MedlinePlus Drug Summary
Vutrisiran is used for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (an inherited condition in which abnormal proteins build up and deposit in tissues, resulting in nerve damage) in adults. Vutrisiran is in a class of medications called small interfering RNAs (siRNAs). It works by decreasing the amount of abnormal proteins and the amount of abnormal protein deposited in the body's tissues, which decreases nerve damage.
Related Packages: 71336-1003-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Vutrisiran Injection
Product Information
| NDC | 71336-1003 |
|---|---|
| Product ID | 71336-1003_0a7f82da-c2c4-4e6d-8708-15d128b6a460 |
| Associated GPIs | 6270609010E520 |
| GCN Sequence Number | 083481 |
| GCN Sequence Number Description | vutrisiran sodium SYRINGE 25MG/0.5ML SUBCUT |
| HIC3 | P9B |
| HIC3 Description | AMYLOIDOSIS AGENTS-TRANSTHYRETIN (TTR) SUPPRESSION |
| GCN | 52467 |
| HICL Sequence Number | 048059 |
| HICL Sequence Number Description | VUTRISIRAN SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | AMVUTTRA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | VUTRISIRAN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/.5mL |
| Substance Name | VUTRISIRAN |
| Labeler Name | Alnylam Pharmaceuticals, Inc. |
| Pharmaceutical Class | Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC], Transthyretin-directed RNA Interaction [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215515 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71336-1003-01 (71336100301)
| NDC Package Code | 71336-1003-1 |
|---|---|
| Billing NDC | 71336100301 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2022-06-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |