NDC 0049-3160

VFEND

Voriconazole

VFEND is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Voriconazole.

• Product ID: 0049-3160_13fd252b-239b-423f-bba1-47b051c7b541
• NDC: 0049-3160
• Product Type: Human Prescription Drug
• Proprietary Name: VFEND
• Generic Name: Voriconazole
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2003-03-28
• Marketing Category: NDA / NDA
• Application Number: NDA021630
• Labeler Name: Roerig
• Substance Name: VORICONAZOLE
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0049-3160-44

1 BOTTLE in 1 CARTON (0049-3160-44) > 75 mL in 1 BOTTLE

• Marketing Start Date: 2003-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-3160-44 [00049316044]

VFEND POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-03-28

Drug Details

Active Ingredients

Ingredient	Strength
VORICONAZOLE	40 mg/mL

OpenFDA Data

• SPL SET ID: ce3ef5cf-3087-4d92-9d94-9eb8287228db
• Manufacturer:
  • Roerig
• UNII:
  • JFU09I87TR
• RxNorm Concept Unique ID - RxCUI:
  • 352220
  • 546624
  • 465355
  • 349435
  • 349434
  • 351209
  • 352219
  • 352218
• UPC Code:
  • 0300493170304

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