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NDC 50419-0385-01 ALIQOPA 15 mg/mL Details
ALIQOPA 15 mg/mL
ALIQOPA is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer HealthCare Pharmaceuticals Inc.. The primary component is COPANLISIB.
MedlinePlus Drug Summary
Copanlisib injection is used to treat people with follicular lymphoma (FL; a slow-growing blood cancer) that has returned after being treated 2 or more times with other medications. Copanlisib injection is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
Related Packages: 50419-0385-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Copanlisib Injection
Product Information
| NDC | 50419-0385 |
|---|---|
| Product ID | 50419-385_209c53a5-83dd-4eae-9f6f-66130657f8e7 |
| Associated GPIs | 21538020102120 |
| GCN Sequence Number | 077717 |
| GCN Sequence Number Description | copanlisib di-HCl VIAL 60 MG INTRAVEN |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 43837 |
| HICL Sequence Number | 044503 |
| HICL Sequence Number Description | COPANLISIB DI-HCL |
| Brand/Generic | Brand |
| Proprietary Name | ALIQOPA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | copanlisib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/mL |
| Substance Name | COPANLISIB |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209936 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0385-01 (50419038501)
| NDC Package Code | 50419-385-01 |
|---|---|
| Billing NDC | 50419038501 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) / 4 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2017-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |