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NDC 15054-0043-01 Onivyde 4.3 mg/mL Details
Onivyde 4.3 mg/mL
Onivyde is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is IRINOTECAN HYDROCHLORIDE.
MedlinePlus Drug Summary
Irinotecan is used alone or in combination with other medications to treat colon or rectal cancer (cancer that begins in the large intestine). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells.
Related Packages: 15054-0043-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Irinotecan Injection
Product Information
| NDC | 15054-0043 |
|---|---|
| Product ID | 15054-0043_5ecd8e9a-b782-47f8-b5de-f19d3f14ebdc |
| Associated GPIs | 21550040202220 |
| GCN Sequence Number | 075024 |
| GCN Sequence Number Description | irinotecan liposomal VIAL 43 MG/10ML INTRAVEN |
| HIC3 | V3E |
| HIC3 Description | ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS |
| GCN | 39929 |
| HICL Sequence Number | 042715 |
| HICL Sequence Number Description | IRINOTECAN LIPOSOMAL |
| Brand/Generic | Brand |
| Proprietary Name | Onivyde |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | IRINOTECAN HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 4.3 |
| Active Ingredient Units | mg/mL |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Labeler Name | Ipsen Biopharmaceuticals, Inc. |
| Pharmaceutical Class | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207793 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 15054-0043-01 (15054004301)
| NDC Package Code | 15054-0043-1 |
|---|---|
| Billing NDC | 15054004301 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2015-10-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |