NDC 70655-002

Fluconazole in Sodium Chloride

Fluconazole, Sodium Chloride

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: 70655-002_451c007f-ae60-407d-ace1-3cfc8a8b2803
• NDC: 70655-002
• 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

Packaging

NDC 70655-002-06

6 BAG in 1 CARTON (70655-002-06) > 100 mL in 1 BAG

• Marketing Start Date: 2018-11-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70655-002-10 [70655000210]

Fluconazole in Sodium Chloride INJECTION

• 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

NDC 70655-002-06 [70655000206]

Fluconazole in Sodium Chloride INJECTION

• 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

Drug Details

Active Ingredients

Ingredient	Strength
FLUCONAZOLE	2 mg/mL

OpenFDA Data

• SPL SET ID: caf4cccd-f295-41da-a82d-3eb02bc8e163
• Manufacturer:
  • Renaissance SSA, LLC
• UNII:
  • 8VZV102JFY
• RxNorm Concept Unique ID - RxCUI:
  • 1721314
  • 1721315

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]

NDC Crossover Matching brand name "Fluconazole in Sodium Chloride" or generic name "Fluconazole, Sodium Chloride"

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