voriconazole

Generic: voriconazole

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

voriconazole 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-321
Product ID 68083-321_0060b9ef-ec03-4b6f-b525-90741a5fb86f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211099
Listing Expiration 2026-12-31
Marketing Start 2020-03-31

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083321
Hyphenated Format 68083-321

Supplemental Identifiers

RxCUI
351209
UPC
0368083321017
UNII
JFU09I87TR
NUI
N0000175487 M0002083 N0000182141 N0000182140 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name voriconazole (source: ndc)
Generic Name voriconazole (source: ndc)
Application Number ANDA211099 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-321-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

voriconazole (10 mg/mL)

Linked Drug Pages (1)

Voriconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0060b9ef-ec03-4b6f-b525-90741a5fb86f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0368083321017"], "unii": ["JFU09I87TR"], "rxcui": ["351209"], "spl_set_id": ["9d5b9457-ac38-4f17-854d-e394c00e273c"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-321-01", "marketing_start_date": "20200331"}], "brand_name": "Voriconazole", "product_id": "68083-321_0060b9ef-ec03-4b6f-b525-90741a5fb86f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "68083-321", "generic_name": "Voriconazole", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA211099", "marketing_category": "ANDA", "marketing_start_date": "20200331", "listing_expiration_date": "20261231"}