Voriconazole NDC 43547-378

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0378Add 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
43547-378-03	43547037803	30 TABLET, COATED in 1 BOTTLE (43547-378-03)Marketed from Oct 28, 2016
43547-378-50	43547037850	500 TABLET, COATED in 1 BOTTLE (43547-378-50)Marketed from Oct 28, 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, Coated
Route: Oral
Labeler: Solco Healthcare U.S., LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206654
Marketing start: Oct 28, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 43547-378_ba05ccd8-a545-4f7a-b343-b8b207080b79SPL ID ba05ccd8-a545-4f7a-b343-b8b207080b79SPL set ID f6a1a792-141b-42e8-8bd1-884e4408eb8aRxCUI 349434, 349435UNII JFU09I87TRUPC 0343547377038, 0343547378035
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

N443547037803 followed by a unit qualifier and the quantity

Package 43547-0378-03. 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 Apr 30, 2026.

Indications (excerpt from the label)

Voriconazole tablets are 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 Aspergi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206654

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

FDA NDC Directory listings under ANDA 206654
Product	Strength	Form · route	Labeler	Product NDC
Voriconazole	Voriconazole 50 mg/1	Tablet, CoatedOral	Solco Healthcare U.S., LLC	43547-377
Voriconazole	Voriconazole 200 mg/1	Tablet, CoatedOral	AvPAK	50268-803