Prescription drug · NDA AUTHORIZED GENERIC
Vusion NDC 0378-8222
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 |
|---|---|---|---|
| 0378-8222-50 | 00378822250 | 1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBEMarketed from Nov 6, 2018 |
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 authorized genericApplication NDA 021026
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0SPL ID 1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0SPL set ID b026bc7d-3a18-41e8-88c4-1e063cd2f42cRxCUI 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
N400378822250followed by a unit qualifier and the quantityPackage 00378-8222-50. 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)
• Miconazole nitrate, zinc oxide and white petrolatum 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 ) • Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes. ( 1.1 ) • Miconazole nitrate, zinc oxide and white petrolatum 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 Miconazole nitrate, zinc oxide and white petrolat…
Excerpt only. Read the full label for complete information.