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NDC 71336-1000-01 Onpattro 2 mg/mL Details
Onpattro 2 mg/mL
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 Information
| NDC | 71336-1000 |
|---|---|
| Product ID | 71336-1000_ffbc20c4-35ca-4779-ab28-57828b566694 |
| Associated GPIs | 62706060102020 |
| GCN Sequence Number | 078738 |
| GCN Sequence Number Description | patisiran sodium,lipid complex VIAL 10 MG/5 ML INTRAVEN |
| HIC3 | P9B |
| HIC3 Description | AMYLOIDOSIS AGENTS-TRANSTHYRETIN (TTR) SUPPRESSION |
| GCN | 45125 |
| HICL Sequence Number | 045155 |
| HICL Sequence Number Description | PATISIRAN SODIUM, LIPID COMPLEX |
| Brand/Generic | Brand |
| Proprietary Name | Onpattro |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | patisiran |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, LIPID COMPLEX |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | PATISIRAN SODIUM |
| 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 | NDA210922 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71336-1000-01 (71336100001)
| NDC Package Code | 71336-1000-1 |
|---|---|
| Billing NDC | 71336100001 |
| Package | 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 |
| Pricing Information | N/A |