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NDC 71288-0105-25 Levoleucovorin 10 mg/mL Details
Levoleucovorin 10 mg/mL
Levoleucovorin is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals 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: 71288-0105-25Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levoleucovorin Injection
Product Information
| NDC | 71288-0105 |
|---|---|
| Product ID | 71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd |
| Associated GPIs | 21755050102021 |
| GCN Sequence Number | 073897 |
| GCN Sequence Number Description | levoleucovorin calcium VIAL 10 MG/ML INTRAVEN |
| HIC3 | V1I |
| HIC3 Description | CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS |
| GCN | 37577 |
| HICL Sequence Number | 011043 |
| HICL Sequence Number Description | LEVOLEUCOVORIN CALCIUM |
| Brand/Generic | Generic |
| Proprietary Name | Levoleucovorin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levoleucovorin calcium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | LEVOLEUCOVORIN CALCIUM |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Pharmaceutical Class | Folate Analog [EPC], Folic Acid [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211002 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 71288-0105-25 (71288010525)
| NDC Package Code | 71288-105-25 |
|---|---|
| Billing NDC | 71288010525 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2019-08-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |