Mitomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Mitomycin.
| Product ID | 68001-391_aad9a9a0-7204-452a-8b9b-6d625c4ee021 |
| NDC | 68001-391 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Mitomycin |
| Generic Name | Mitomycin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-05-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA064144 |
| Labeler Name | BluePoint Laboratories |
| Substance Name | MITOMYCIN |
| Active Ingredient Strength | 40 mg/80mL |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-05-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA064144 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA064144 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-14 |
| Ingredient | Strength |
|---|---|
| MITOMYCIN | 40 mg/80mL |
| SPL SET ID: | aad9a9a0-7204-452a-8b9b-6d625c4ee021 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9135 | Mitomycin | Mitomycin |
| 0143-9136 | Mitomycin | Mitomycin |
| 0143-9279 | Mitomycin | Mitomycin |
| 0143-9280 | Mitomycin | Mitomycin |
| 16729-108 | Mitomycin | Mitomycin |
| 16729-115 | Mitomycin | Mitomycin |
| 16729-116 | Mitomycin | Mitomycin |
| 16729-246 | Mitomycin | Mitomycin |
| 16729-247 | Mitomycin | Mitomycin |
| 16729-248 | Mitomycin | Mitomycin |
| 67457-518 | Mitomycin | Mitomycin |
| 67457-519 | Mitomycin | Mitomycin |
| 67457-520 | Mitomycin | Mitomycin |
| 67457-995 | Mitomycin | Mitomycin |
| 67457-996 | Mitomycin | Mitomycin |
| 67457-997 | Mitomycin | Mitomycin |
| 68001-389 | Mitomycin | Mitomycin |
| 68001-390 | Mitomycin | Mitomycin |
| 68001-391 | Mitomycin | Mitomycin |
| 68083-483 | MITOMYCIN | MITOMYCIN |
| 68083-484 | MITOMYCIN | MITOMYCIN |
| 68083-502 | MITOMYCIN | MITOMYCIN |
| 71288-137 | MITOMYCIN | MITOMYCIN |
| 71288-138 | MITOMYCIN | MITOMYCIN |
| 69605-103 | JELMYTO | mitomycin |
| 49771-002 | Mitosol | mitomycin |
| 69448-001 | MUTAMYCIN | Mitomycin |
| 69448-002 | MUTAMYCIN | Mitomycin |
| 69448-003 | MUTAMYCIN | Mitomycin |