Prescription drug · NDA
Vusion NDC 0378-9730
miconazole nitrate, zinc oxide, white petrolatum · Miconazole nitrate 2.5 mg/g + 2 more ingredients · Ointment · Topical · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9730-50 | 00378973050 | 1 TUBE in 1 CARTON (0378-9730-50) / 50 g in 1 TUBEMarketed from Feb 6, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vusion
- Generic name (nonproprietary)
- miconazole nitrate, zinc oxide, white petrolatum
- Active ingredients
- Miconazole nitrate — 2.5 mg/gZinc oxide — 150 mg/gPetrolatum — 813.5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021026
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0378-9730_64bcb02d-a570-4985-81f4-9b4a415488c5SPL ID 64bcb02d-a570-4985-81f4-9b4a415488c5SPL set ID b44b452d-3630-4cb5-8ed1-1f8edac4690cRxCUI 831391, 831393UNII VW4H1CYW1K, SOI2LOH54Z, 4T6H12BN9U
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400378973050followed by a unit qualifier and the quantityPackage 00378-9730-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
• VUSION Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. ( 1.1 ) • VUSION Ointment should not be used as a substitute for frequent diaper changes. ( 1.1 ) • VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. ( 1.2 ) 1.1 Indication VUSION Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yea…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021026
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vusionmiconazole nitrate, zinc oxide, white petrolatum | Miconazole nitrate 2.5 mg/g + 2 more ingredients | OintmentTopical | Mylan Pharmaceuticals Inc. | 0378-8222 |
- openFDA data updated
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