NDC codes

FDA NDC Directory
Product NDC (as listed)0781-5667Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-5667Add 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
0781-5667-050078156670500781566705500 TABLET, FILM COATED in 1 BOTTLE (0781-5667-05)Marketed from Dec 12, 2011
0781-5667-1000781566710007815667101000 TABLET, FILM COATED in 1 BOTTLE (0781-5667-10)Marketed from Dec 12, 2011
0781-5667-13007815667130078156671310 BLISTER PACK in 1 CARTON (0781-5667-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5667-06)Marketed from Dec 12, 2011
0781-5667-31007815667310078156673130 TABLET, FILM COATED in 1 BOTTLE (0781-5667-31)Marketed from Dec 12, 2011

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 — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sandoz IncNDC labeler code 0781
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 0781-5667_efbbf86a-b798-4963-8786-0d7033ee908bSPL ID efbbf86a-b798-4963-8786-0d7033ee908bSPL set ID e2b3c0b3-02a6-45c3-a8ea-05d210dc9108RxCUI 349434, 349435UNII JFU09I87TRUPC 0307815668310, 0307815667313
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

N400781566705 followed by a unit qualifier and the quantity

Package 00781-5667-05. 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 Aspe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5667

What is NDC 0781-5667?
0781-5667 is the product NDC for voriconazole, Voriconazole 50 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. 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?
Sandoz Inc, NDC labeler code 0781. 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 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 coatedOralSandoz Inc0781-5668
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8734
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2911
voriconazoleVoriconazole 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1198

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