NDC 0378-9730

VUSION

Miconazole Nitrate, Zinc Oxide, White Petrolatum

VUSION is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Miconazole Nitrate; Zinc Oxide; Petrolatum.

• Product ID: 0378-9730_9b6275e8-ab60-4219-a51e-4089bbdc7482
• NDC: 0378-9730
• Product Type: Human Prescription Drug
• Proprietary Name: VUSION
• Generic Name: Miconazole Nitrate, Zinc Oxide, White Petrolatum
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2006-02-16
• Marketing Category: NDA / NDA
• Application Number: NDA021026
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: MICONAZOLE NITRATE; ZINC OXIDE; PETROLATUM
• Active Ingredient Strength: 3 mg/g; mg/g; mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-9730-50

1 TUBE in 1 CARTON (0378-9730-50) > 50 g in 1 TUBE

• Marketing Start Date: 2020-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9730-50 [00378973050]

VUSION OINTMENT

• Marketing Category: NDA
• Application Number: NDA021026
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2020-02-06

Drug Details

Active Ingredients

Ingredient	Strength
MICONAZOLE NITRATE	2.5 mg/g

OpenFDA Data

• SPL SET ID: b44b452d-3630-4cb5-8ed1-1f8edac4690c
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • SOI2LOH54Z
  • VW4H1CYW1K
  • 4T6H12BN9U
• RxNorm Concept Unique ID - RxCUI:
  • 831393
  • 831391

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "VUSION" or generic name "Miconazole Nitrate, Zinc Oxide, White Petrolatum"

NDC	Brand Name	Generic Name
0378-8222	VUSION	miconazole nitrate, zinc oxide, white petrolatum
0378-9730	VUSION	miconazole nitrate, zinc oxide, white petrolatum
40076-002	VUSION	miconazole nitrate, zinc oxide, white petrolatum