voriconazole NDC 43386-089

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-089Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0089Add 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 NDC	11-digit (billing)	Package	Copy
43386-089-03	43386008903	30 TABLET, FILM COATED in 1 BOTTLE (43386-089-03)Marketed from May 24, 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
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207371
Marketing start: May 24, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 43386-089_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6eSPL ID 56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6eSPL set ID b4c934c0-c1bb-4b0a-bc32-fb9e77ef65fcRxCUI 349434, 349435UNII JFU09I87TRUPC 0343386089055
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

N443386008903 followed by a unit qualifier and the quantity

Package 43386-0089-03. 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 Jan 31, 2024.

Indications (excerpt from the label)

Voriconazole is 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 is 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 fumigatus . There …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207371

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

FDA NDC Directory listings under ANDA 207371
Product	Strength	Form · route	Labeler	Product NDC
voriconazole	Voriconazole 50 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals,Inc.	43386-088