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NDC 55292-0811-55 Cosmegen 0.5 mg/mL Details
Cosmegen 0.5 mg/mL
Cosmegen is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is DACTINOMYCIN.
MedlinePlus Drug Summary
Dactinomycin is used in combination with other medications, surgery, and/or radiation therapy to treat Wilms' tumor (a type of kidney cancer that occurs in children) and rhabdomyosarcoma (cancer that forms in muscles) in children. Dactinomycin is also used in combination with other medications to treat certain types of testicular cancer and Ewing's sarcoma (a type of cancer in bones or muscles). Dactinomycin is also used alone or in combination with other medications to treat gestational trophoblastic tumors (a type of tumor that forms inside a woman's uterus while she is pregnant). Dactinomycin may also be used to treat certain types of cancerous tumors that are located in a specific area of the body. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 55292-0811-55Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dactinomycin
Product Information
| NDC | 55292-0811 |
|---|---|
| Product ID | 55292-811_2afdf978-8e90-40e9-872f-9f8775dcd41c |
| Associated GPIs | 21200020002105 |
| GCN Sequence Number | 034676 |
| GCN Sequence Number Description | dactinomycin VIAL 0.5 MG INTRAVEN |
| HIC3 | V1D |
| HIC3 Description | ANTIBIOTIC ANTINEOPLASTICS |
| GCN | 96679 |
| HICL Sequence Number | 003914 |
| HICL Sequence Number Description | DACTINOMYCIN |
| Brand/Generic | Brand |
| Proprietary Name | Cosmegen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dactinomycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | DACTINOMYCIN |
| Labeler Name | Recordati Rare Diseases, Inc. |
| Pharmaceutical Class | Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050682 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55292-0811-55 (55292081155)
| NDC Package Code | 55292-811-55 |
|---|---|
| Billing NDC | 55292081155 |
| Package | 12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) / 1 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 1964-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |