NDC codes

FDA NDC Directory
Product NDC (as listed)65862-891Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0891Add 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
65862-891-016586208910165862089101100 TABLET, FILM COATED in 1 BOTTLE (65862-891-01)Marketed from Jan 22, 2016
65862-891-0365862089103658620891033 BLISTER PACK in 1 CARTON (65862-891-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-891-10)Marketed from Jan 22, 2016
65862-891-056586208910565862089105500 TABLET, FILM COATED in 1 BOTTLE (65862-891-05)Marketed from Jan 22, 2016
65862-891-30658620891306586208913030 TABLET, FILM COATED in 1 BOTTLE (65862-891-30)Marketed from Jan 22, 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 — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206837
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 65862-891_3182e52d-c1d5-4af5-8081-cf382176638fSPL ID 3182e52d-c1d5-4af5-8081-cf382176638fSPL set ID 4fe672ff-2cef-4f88-ab85-5a4b586da20dRxCUI 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

N465862089101 followed by a unit qualifier and the quantity

Package 65862-0891-01. 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 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-891

What is NDC 65862-891?
65862-891 is the product NDC for Voriconazole, Voriconazole 50 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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?
51 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 52 Voriconazole NDCs

Other NDCs under ANDA 206837

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

FDA NDC Directory listings under ANDA 206837
ProductStrengthForm · routeLabelerProduct NDC
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-198
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-199
VoriconazoleVoriconazole 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-968
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-979
VoriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-892

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