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NDC 00310-3040-00 SAPHNELO 300 mg/2mL Details
SAPHNELO 300 mg/2mL
SAPHNELO is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is ANIFROLUMAB.
MedlinePlus Drug Summary
Anifrolumab is used with other medications to treat moderate to severe systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs) in adults. Anifrolumab injection is in a class of medications called monoclonal antibodies. It works by blocking the activity of a certain protein in people with SLE.
Related Packages: 00310-3040-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Anifrolumab-fnia Injection
Product Information
| NDC | 00310-3040 |
|---|---|
| Product ID | 0310-3040_3f2b76dd-4c0c-4d2c-ba03-762f92b00153 |
| Associated GPIs | 99427010252020 |
| GCN Sequence Number | 082546 |
| GCN Sequence Number Description | anifrolumab-fnia VIAL 300 MG/2ML INTRAVEN |
| HIC3 | Z25 |
| HIC3 Description | IMMUNOSUPPRESSANT-INTERFERON INHIBITOR, MAB |
| GCN | 49997 |
| HICL Sequence Number | 047512 |
| HICL Sequence Number Description | ANIFROLUMAB-FNIA |
| Brand/Generic | Brand |
| Proprietary Name | SAPHNELO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Anifrolumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/2mL |
| Substance Name | ANIFROLUMAB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761123 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-3040-00 (00310304000)
| NDC Package Code | 0310-3040-00 |
|---|---|
| Billing NDC | 00310304000 |
| Package | 1 VIAL, GLASS in 1 CARTON (0310-3040-00) / 2 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2021-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |