Fluconazole in Sodium Chloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Renaissance Ssa, Llc. The primary component is Fluconazole.
| Product ID | 70655-088_451c007f-ae60-407d-ace1-3cfc8a8b2803 |
| NDC | 70655-088 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluconazole in Sodium Chloride |
| Generic Name | Fluconazole, Sodium Chloride |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-09-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076766 |
| Labeler Name | Renaissance SSA, LLC |
| Substance Name | FLUCONAZOLE |
| Active Ingredient Strength | 2 mg/mL |
| Pharm Classes | Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-09-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076766 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-11-08 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA076766 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-09-12 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| FLUCONAZOLE | 2 mg/mL |
| SPL SET ID: | caf4cccd-f295-41da-a82d-3eb02bc8e163 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-4688 | Fluconazole in Sodium Chloride | Fluconazole in Sodium Chloride |
| 69784-002 | Fluconazole in Sodium Chloride | Fluconazole, Sodium Chloride |
| 69784-003 | Fluconazole in Sodium Chloride | Fluconazole, Sodium Chloride |
| 69784-261 | Fluconazole in Sodium Chloride | Fluconazole, Sodium Chloride |
| 70655-002 | Fluconazole in Sodium Chloride | Fluconazole, Sodium Chloride |
| 70655-088 | Fluconazole in Sodium Chloride | Fluconazole, Sodium Chloride |