NDC codes

FDA NDC Directory
Product NDC (as listed)16714-199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0199Add 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
16714-199-011671401990130 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)Marketed from Jan 22, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Voriconazole
Generic name (nonproprietary)
voriconazole
Active ingredients
Voriconazole — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206837
Marketing start
Marketing end
Other FDA classes
Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 16714-199_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7fSPL ID 45de5a3f-4e1f-4870-b4aa-3057e4e2ba7fSPL set ID b38165a5-d8d4-4579-a49a-fbe92e764089RxCUI 349434, 349435UNII JFU09I87TRUPC 0316714198019, 0316714199016
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416714019901 followed by a unit qualifier and the quantity

Package 16714-0199-01. 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)

Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis ( 1.1 ) Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) Esophageal candidiasis ( 1.3 ) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206837

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

FDA NDC Directory listings under ANDA 206837
ProductStrengthForm · routeLabelerProduct NDC
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-198
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-968
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-979
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-892
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-891

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