NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3416Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3416Add 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
0781-3416-94007813416941 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USEMarketed from May 30, 2012

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)
Voriconazole
Generic name (nonproprietary)
voriconazole
Active ingredients
Voriconazole — 10 mg/mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090862
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 0781-3416_aef09a5b-01be-4649-a0d7-fe7c187c8ce1SPL ID aef09a5b-01be-4649-a0d7-fe7c187c8ce1SPL set ID e648a0e4-f324-49dc-a8f6-cf25ff3b2dfeRxCUI 351209UNII JFU09I87TR
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400781341694 followed by a unit qualifier and the quantity

Package 00781-3416-94. 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 for injection 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 for injection 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090862

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

FDA NDC Directory listings under ANDA 090862
ProductStrengthForm · routeLabelerProduct NDC
VoriconazoleVoriconazole 10 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousCivica, Inc.72572-875

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