NDC codes

FDA NDC Directory
Product NDC (as listed)65841-831Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0831Add 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
65841-831-0165841083101100 TABLET, FILM COATED in 1 BOTTLE (65841-831-01)Marketed from May 25, 2016
65841-831-0565841083105500 TABLET, FILM COATED in 1 BOTTLE (65841-831-05)Marketed from May 25, 2016
65841-831-066584108310630 TABLET, FILM COATED in 1 BOTTLE (65841-831-06)Marketed from May 25, 2016
65841-831-10658410831101000 TABLET, FILM COATED in 1 BOTTLE (65841-831-10)Marketed from May 25, 2016
65841-831-166584108311690 TABLET, FILM COATED in 1 BOTTLE (65841-831-16)Marketed from May 25, 2016
65841-831-776584108317710 BLISTER PACK in 1 CARTON (65841-831-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-831-30)Marketed from May 25, 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
Voriconazole200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206747
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 65841-831_7666344f-3ba8-4a08-a828-65b846868dc0SPL ID 7666344f-3ba8-4a08-a828-65b846868dc0SPL set ID bda70104-d84b-4d3f-9ca0-5f4f1ca816adRxCUI 349434, 349435UNII JFU09I87TRUPC 0365841831016, 0365841830019
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

N465841083101 followed by a unit qualifier and the quantity

Package 65841-0831-01. 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 is an azole antifungal indicated for the treatment of adults and pediatric patients aged 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 fumi

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206747

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

FDA NDC Directory listings under ANDA 206747
ProductStrengthForm · routeLabelerProduct NDC
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-063
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-062
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-830
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6596

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