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NDC 65219-0568-00 MITOMYCIN 40 mg/80mL Details
MITOMYCIN 40 mg/80mL
MITOMYCIN is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is MITOMYCIN.
MedlinePlus Drug Summary
Mitomycin is used in combination with other medications to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.
Related Packages: 65219-0568-00Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Mitomycin
Product Information
| NDC | 65219-0568 |
|---|---|
| Product ID | 65219-568_c8893d3b-e9e0-4ab1-8c6d-376a7f1037bc |
| Associated GPIs | |
| GCN Sequence Number | 008821 |
| GCN Sequence Number Description | mitomycin VIAL 40 MG INTRAVEN |
| HIC3 | V1D |
| HIC3 Description | ANTIBIOTIC ANTINEOPLASTICS |
| GCN | 38602 |
| HICL Sequence Number | 003917 |
| HICL Sequence Number Description | MITOMYCIN |
| Brand/Generic | Generic |
| Proprietary Name | MITOMYCIN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MITOMYCIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/80mL |
| Substance Name | MITOMYCIN |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216648 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0568-00 (65219056800)
| NDC Package Code | 65219-568-00 |
|---|---|
| Billing NDC | 65219056800 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |