NDC codes

FDA NDC Directory
Product NDC (as listed)0378-9730Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-9730Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0378-9730-50003789730501 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 nitrate2.5 mg/gZinc oxide150 mg/gPetrolatum813.5 mg/g
Dosage form
Ointment
Route
Topical
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

N400378973050 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021026

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021026
ProductStrengthForm · routeLabelerProduct NDC
Vusionmiconazole nitrate, zinc oxide, white petrolatumMiconazole nitrate 2.5 mg/g + 2 more ingredientsOintmentTopicalMylan Pharmaceuticals Inc.0378-8222

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