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NDC 65219-0133-20 Cyclophosphamide 2 g/100mL Details
Cyclophosphamide 2 g/100mL
Cyclophosphamide is a INTRAVENOUS; ORAL INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is CYCLOPHOSPHAMIDE.
MedlinePlus Drug Summary
Cyclophosphamide is used alone or in combination with other medications to treat Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection); cutaneous T-cell lymphoma (CTCL, a group of cancers of the immune system that first appear as skin rashes); multiple myeloma (a type of cancer of the bone marrow); and certain types of leukemia (cancer of the white blood cells), including chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), acute myeloid leukemia (AML, ANLL), and acute lymphoblastic leukemia (ALL). It is also used to treat retinoblastoma (cancer in the eye), neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children), ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), and breast cancer. Cyclophosphamide is also used to treat nephrotic syndrome (a disease that is caused by damage to the kidneys) in children whose disease has not improved, has gotten worse, or has come back after taking other medications or in children who experienced intolerable side effects with other medications. Cyclophosphamide is in a class of medications called alkylating agents. When cyclophosphamide is used to treat cancer, it works by slowing or stopping the growth of cancer cells in your body. When cyclophosphamide is used to treat nephrotic syndrome, it works by suppressing your body's immune system.
Related Packages: 65219-0133-20Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Cyclophosphamide Injection
Product Information
NDC | 65219-0133 |
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Product ID | 65219-133_b11946ea-c5bc-4cc0-9f2c-2198dbc62ddd |
Associated GPIs | |
GCN Sequence Number | 008767 |
GCN Sequence Number Description | cyclophosphamide VIAL 2 G INTRAVEN |
HIC3 | V1A |
HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
GCN | 38357 |
HICL Sequence Number | 003893 |
HICL Sequence Number Description | CYCLOPHOSPHAMIDE |
Brand/Generic | Generic |
Proprietary Name | Cyclophosphamide |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | cyclophosphamide |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Route | INTRAVENOUS; ORAL |
Active Ingredient Strength | 2 |
Active Ingredient Units | g/100mL |
Substance Name | CYCLOPHOSPHAMIDE |
Labeler Name | Fresenius Kabi USA, LLC |
Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA204555 |
Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0133-20 (65219013320)
NDC Package Code | 65219-133-20 |
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Billing NDC | 65219013320 |
Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-133-20) / 100 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2023-11-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |