NDC codes

FDA NDC Directory
Product NDC (as listed)72578-063Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72578-0063Add 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
72578-063-017257800630172578006301100 TABLET, FILM COATED in 1 BOTTLE (72578-063-01)Marketed from Apr 16, 2019
72578-063-057257800630572578006305500 TABLET, FILM COATED in 1 BOTTLE (72578-063-05)Marketed from Apr 16, 2019
72578-063-06725780063067257800630630 TABLET, FILM COATED in 1 BOTTLE (72578-063-06)Marketed from Apr 16, 2019
72578-063-1072578006310725780063101000 TABLET, FILM COATED in 1 BOTTLE (72578-063-10)Marketed from Apr 16, 2019
72578-063-16725780063167257800631690 TABLET, FILM COATED in 1 BOTTLE (72578-063-16)Marketed from Apr 16, 2019
72578-063-77725780063777257800637710 BLISTER PACK in 1 CARTON (72578-063-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72578-063-30)Marketed from Apr 16, 2019

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
Viona Pharmaceuticals IncNDC labeler code 72578
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 72578-063_66fc1497-5ec6-40b6-b77c-9decfe476c9cSPL ID 66fc1497-5ec6-40b6-b77c-9decfe476c9cSPL set ID 75fcbea8-8eeb-4528-b7d9-a059dd25da83RxCUI 349434, 349435UNII 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

N472578006301 followed by a unit qualifier and the quantity

Package 72578-0063-01. 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)

About NDC 72578-063

What is NDC 72578-063?
72578-063 is the product NDC for voriconazole, Voriconazole 200 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
voriconazole.
What is the active ingredient?
Voriconazole.
Who is the labeler?
Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for voriconazole?
52 other product NDCs are listed under this name. See all voriconazole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other voriconazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-96860687-0968-21
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-97960687-0979-21
Voriconazolevoriconazole injectionVoriconazole 10 mg/mLInjectionIntravenousPAI Holdings, LLC dba PAI Pharma0121-109100121-1091-55
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralSafecor Health LLC48433-14648433-0146-03
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralSafecor Health LLC48433-14748433-0147-03
VoriconazoleVoriconazole 10 mg/mLInjection, SolutionIntravenousHainan Poly Pharm. Co., Ltd.14335-73014335-0730-10
VoriconazoleVoriconazole 40 mg/mLPowder, For suspensionOralCamber Pharmaceuticals, Inc.31722-26631722-0266-31
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-119872162-1198-03
voriconazoleVoriconazole 40 mg/mLPowder, For suspensionOralZhejiang Poly Pharm Co., Ltd.72673-11172673-0111-30
VoriconazoleVoriconazole 10 mg/mLInjection, Powder, Lyophilized, For solutionIntravenousCamber Pharmaceuticals, Inc.31722-22431722-0224-31

All 53 voriconazole NDCs

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 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6596
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-830
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-831
voriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-062

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