NDC 0049-4190

VFEND

Voriconazole

VFEND is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Voriconazole.

• Product ID: 0049-4190_4be3e0d5-6bae-4ebb-8691-cec3d1781ec9
• NDC: 0049-4190
• Product Type: Human Prescription Drug
• Proprietary Name: VFEND
• Generic Name: Voriconazole
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-10-24
• Marketing Category: NDA / NDA
• Application Number: NDA021267
• Labeler Name: Roerig
• Substance Name: VORICONAZOLE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0049-4190-01

1 VIAL, SINGLE-USE in 1 CARTON (0049-4190-01) > 20 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2012-10-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-4190-01 [00049419001]

VFEND INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021267
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-10-24

Drug Details

Active Ingredients

Ingredient	Strength
VORICONAZOLE	10 mg/mL

OpenFDA Data

• SPL SET ID: 08d08721-1f4c-478a-8abf-d9c402d50553
• Manufacturer:
  • Roerig
• UNII:
  • JFU09I87TR
• RxNorm Concept Unique ID - RxCUI:
  • 352220
  • 351209

Pharmacological Class

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

NDC Crossover Matching brand name "VFEND" or generic name "Voriconazole"

NDC	Brand Name	Generic Name
0049-3160	VFEND	voriconazole
0049-3170	VFEND	voriconazole
0049-3180	VFEND	voriconazole
0049-3190	VFEND	voriconazole
55154-2725	VFEND	VFEND
0049-4190	VFEND	VFEND