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NDC 72893-0009-01 Fusilev 50 mg/5mL Details
Fusilev 50 mg/5mL
Fusilev is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acrotech Biopharma Inc. The primary component is LEVOLEUCOVORIN CALCIUM.
MedlinePlus Drug Summary
Levoleucovorin injection is used in adults and children to prevent harmful effects of methotrexate (Trexall) when methotrexate is used to treat osteosarcoma (cancer that forms in bones). Levoleucovorin injection is also used to treat adults and children who have accidentally received an overdose of methotrexate or similar medications or who are not able to eliminate these medications properly from their bodies. Levoleucovorin injection is also used with fluorouracil (5-FU, a chemotherapy medication) to treat adults with colorectal cancer (cancer that begins in the large intestine) that has spread to other parts of the body. Levoleucovorin injection is in a class of medications called folic acid analogs. It works to prevent the harmful effects of methotrexate by protecting healthy cells, while allowing methotrexate to enter and kill cancer cells. It works to treat colorectal cancer by increasing the effects of fluorouracil.
Related Packages: 72893-0009-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levoleucovorin Injection
Product Information
| NDC | 72893-0009 |
|---|---|
| Product ID | 72893-009_c1e3b82a-8c60-45eb-976b-3e33f42710e2 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fusilev |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levoleucovorin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LEVOLEUCOVORIN CALCIUM |
| Labeler Name | Acrotech Biopharma Inc |
| Pharmaceutical Class | Folate Analog [EPC], Folic Acid [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020140 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72893-0009-01 (72893000901)
| NDC Package Code | 72893-009-01 |
|---|---|
| Billing NDC | 72893000901 |
| Package | 1 VIAL in 1 CARTON (72893-009-01) / 5 mL in 1 VIAL |
| Marketing Start Date | 2008-08-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |