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NDC 71336-1002-01 OXLUMO 94.5 mg/.5mL Details
OXLUMO 94.5 mg/.5mL
OXLUMO is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alnylam Pharmaceuticals, Inc.. The primary component is LUMASIRAN.
Product Information
| NDC | 71336-1002 |
|---|---|
| Product ID | 71336-1002_0597bb76-a942-459f-93b6-c3612adaf59b |
| Associated GPIs | 56626040202020 |
| GCN Sequence Number | 081716 |
| GCN Sequence Number Description | lumasiran sodium VIAL 94.5MG/0.5 SUBCUT |
| HIC3 | Z1N |
| HIC3 Description | OXALOSIS AGENT - OXALATE INHIBITOR, SIRNA BASED |
| GCN | 48913 |
| HICL Sequence Number | 046999 |
| HICL Sequence Number Description | LUMASIRAN SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | OXLUMO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lumasiran |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 94.5 |
| Active Ingredient Units | mg/.5mL |
| Substance Name | LUMASIRAN |
| Labeler Name | Alnylam Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214103 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71336-1002-01 (71336100201)
| NDC Package Code | 71336-1002-1 |
|---|---|
| Billing NDC | 71336100201 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2020-11-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |