NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8734Add 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
63629-8734-16362987340130 TABLET, FILM COATED in 1 BOTTLE (63629-8734-1)Marketed from Dec 12, 2011

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 200265
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 63629-8734_d7d66c66-0efb-4ad0-9245-2ed7790b0e0aSPL ID d7d66c66-0efb-4ad0-9245-2ed7790b0e0aSPL set ID 711e5a1b-8c40-4b18-9f4f-12c8ab351012RxCUI 349434UNII 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 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

N463629873401 followed by a unit qualifier and the quantity

Package 63629-8734-01. 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 aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight 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 (aged 12 to 14 years weighing greater than or …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200265

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

FDA NDC Directory listings under ANDA 200265
ProductStrengthForm · routeLabelerProduct NDC
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2911
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralSandoz Inc0781-5667
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralSandoz Inc0781-5668
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1198

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