voriconazole

Generic: voriconazole

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler mylan institutional inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 200 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-165
Product ID 51079-165_3a879fbf-a5ce-949d-e063-6394a90a90d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090547
Listing Expiration 2026-12-31
Marketing Start 2011-08-08

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 51079165
Hyphenated Format 51079-165

Supplemental Identifiers

RxCUI
349434 349435
UNII
JFU09I87TR
NUI
N0000175487 M0002083 N0000182141 N0000182140 N0000185504

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 ANDA090547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (51079-165-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-165-01)
source: ndc

Packages (1)

51079-165-03 30 BLISTER PACK in 1 CARTON (51079-165-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-165-01)

Ingredients (1)

voriconazole (200 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": "3a879fbf-a5ce-949d-e063-6394a90a90d5", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["3af8cfe6-1c0d-4b57-ae31-05cffa64132e"], "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": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (51079-165-03)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-165-01)", "package_ndc": "51079-165-03", "marketing_start_date": "20110808"}], "brand_name": "Voriconazole", "product_id": "51079-165_3a879fbf-a5ce-949d-e063-6394a90a90d5", "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": "51079-165", "generic_name": "voriconazole", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA090547", "marketing_category": "ANDA", "marketing_start_date": "20110808", "listing_expiration_date": "20261231"}