Dactinomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Dactinomycin.
| Product ID | 67457-513_028310eb-7a34-470d-9041-cee58fd3622c |
| NDC | 67457-513 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dactinomycin |
| Generic Name | Dactinomycin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203385 |
| Labeler Name | Mylan Institutional LLC |
| Substance Name | DACTINOMYCIN |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203385 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-01 |
| Marketing End Date | 2019-10-31 |
| Marketing Category | ANDA |
| Application Number | ANDA203385 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-01 |
| Ingredient | Strength |
|---|---|
| DACTINOMYCIN | .5 mg/mL |
| SPL SET ID: | 5dc19443-1bac-4bb4-893e-e791b72b3d26 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 39822-2100 | dactinomycin | dactinomycin |
| 42658-008 | Dactinomycin | dactinomycin |
| 55150-431 | DACTINOMYCIN | DACTINOMYCIN |
| 55150-928 | DACTINOMYCIN | DACTINOMYCIN |
| 66993-489 | Dactinomycin | Dactinomycin |
| 67457-513 | Dactinomycin | Dactinomycin |
| 67457-928 | Dactinomycin | Dactinomycin |
| 71288-129 | Dactinomycin | Dactinomycin |
| 55292-811 | Cosmegen | dactinomycin |