What is NDC 68083-321?

68083-321 is the product NDC for Voriconazole, Voriconazole 10 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Voriconazole NDC 68083-321 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-321Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0321Add 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 NDC	11-digit (billing)	Package	Copy
68083-321-01	6808303210168083032101	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 31, 2020

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 — 10 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211099
Marketing start: Mar 31, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 68083-321_9f57066e-9301-4770-87df-29a62a42deccSPL ID 9f57066e-9301-4770-87df-29a62a42deccSPL set ID 9d5b9457-ac38-4f17-854d-e394c00e273cRxCUI 351209UNII JFU09I87TRUPC 0368083321017
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

N468083032101 followed by a unit qualifier and the quantity

Package 68083-0321-01. 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 Mar 5, 2026.

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)

About NDC 68083-321

What is NDC 68083-321?: 68083-321 is the product NDC for Voriconazole, Voriconazole 10 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, 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?: Gland Pharma Limited, NDC labeler code 68083. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Voriconazole	Voriconazole 50 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-968	60687-0968-21
Voriconazole	Voriconazole 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-979	60687-0979-21
Voriconazolevoriconazole injection	Voriconazole 10 mg/mL	InjectionIntravenous	PAI Holdings, LLC dba PAI Pharma	0121-1091	00121-1091-55
Voriconazole	Voriconazole 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-146	48433-0146-03
Voriconazole	Voriconazole 200 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-147	48433-0147-03
Voriconazole	Voriconazole 10 mg/mL	Injection, SolutionIntravenous	Hainan Poly Pharm. Co., Ltd.	14335-730	14335-0730-10
Voriconazole	Voriconazole 40 mg/mL	Powder, For suspensionOral	Camber Pharmaceuticals, Inc.	31722-266	31722-0266-31
voriconazole	Voriconazole 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1198	72162-1198-03
voriconazole	Voriconazole 40 mg/mL	Powder, For suspensionOral	Zhejiang Poly Pharm Co., Ltd.	72673-111	72673-0111-30
Voriconazole	Voriconazole 10 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Camber Pharmaceuticals, Inc.	31722-224	31722-0224-31

All 53 Voriconazole NDCs

Other NDCs under ANDA 211099

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

FDA NDC Directory listings under ANDA 211099
Product	Strength	Form · route	Labeler	Product NDC
Voriconazole	Voriconazole 10 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	65219-190
Voriconazole	Voriconazole 10 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fosun Pharma USA Inc.	72266-131