voriconazole

Generic: voriconazole

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 50 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-062
Product ID 72578-062_66fc1497-5ec6-40b6-b77c-9decfe476c9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206747
Listing Expiration 2027-12-31
Marketing Start 2019-04-16

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 72578062
Hyphenated Format 72578-062

Supplemental Identifiers

RxCUI
349434 349435
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 ANDA206747 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72578-062-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72578-062-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72578-062-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72578-062-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72578-062-16)
  • 10 BLISTER PACK in 1 CARTON (72578-062-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72578-062-30)
source: ndc

Packages (6)

72578-062-01 100 TABLET, FILM COATED in 1 BOTTLE (72578-062-01) 72578-062-05 500 TABLET, FILM COATED in 1 BOTTLE (72578-062-05) 72578-062-06 30 TABLET, FILM COATED in 1 BOTTLE (72578-062-06) 72578-062-10 1000 TABLET, FILM COATED in 1 BOTTLE (72578-062-10) 72578-062-16 90 TABLET, FILM COATED in 1 BOTTLE (72578-062-16) 72578-062-77 10 BLISTER PACK in 1 CARTON (72578-062-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72578-062-30)

Ingredients (1)

voriconazole (50 mg/1)

Linked Drug Pages (1)

voriconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "66fc1497-5ec6-40b6-b77c-9decfe476c9c", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["75fcbea8-8eeb-4528-b7d9-a059dd25da83"], "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": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72578-062-01)", "package_ndc": "72578-062-01", "marketing_start_date": "20190416"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72578-062-05)", "package_ndc": "72578-062-05", "marketing_start_date": "20190416"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72578-062-06)", "package_ndc": "72578-062-06", "marketing_start_date": "20190416"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72578-062-10)", "package_ndc": "72578-062-10", "marketing_start_date": "20190416"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72578-062-16)", "package_ndc": "72578-062-16", "marketing_start_date": "20190416"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-062-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (72578-062-30)", "package_ndc": "72578-062-77", "marketing_start_date": "20190416"}], "brand_name": "voriconazole", "product_id": "72578-062_66fc1497-5ec6-40b6-b77c-9decfe476c9c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "72578-062", "generic_name": "voriconazole", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "50 mg/1"}], "application_number": "ANDA206747", "marketing_category": "ANDA", "marketing_start_date": "20190416", "listing_expiration_date": "20271231"}