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NDC 75987-0150-03 UPLIZNA 10 mg/mL Details
UPLIZNA 10 mg/mL
UPLIZNA is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is INEBILIZUMAB.
Product Information
| NDC | 75987-0150 |
|---|---|
| Product ID | 75987-150_9798b7eb-ddc0-4efb-8f92-bf6a82dbf269 |
| Associated GPIs | 99405040202020 |
| GCN Sequence Number | 081189 |
| GCN Sequence Number Description | inebilizumab-cdon VIAL 100MG/10ML INTRAVEN |
| HIC3 | Z27 |
| HIC3 Description | ANTI-CD19 (B LYMPHOCYTE) MONOCLONAL ANTIBODY |
| GCN | 48233 |
| HICL Sequence Number | 046617 |
| HICL Sequence Number Description | INEBILIZUMAB-CDON |
| Brand/Generic | Brand |
| Proprietary Name | UPLIZNA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Inebilizumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | INEBILIZUMAB |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Pharmaceutical Class | CD19-directed Antibody Interactions [MoA], CD19-directed Cytolytic Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761142 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75987-0150-03 (75987015003)
| NDC Package Code | 75987-150-03 |
|---|---|
| Billing NDC | 75987015003 |
| Package | 3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01) |
| Marketing Start Date | 2020-06-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |