voriconazole

Generic: voriconazole

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

Drug Facts

Product Profile

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

voriconazole 50 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1626
Product ID 0378-1626_32d3b3c7-0c9c-4b78-833e-b2acf9745ce9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090547
Listing Expiration 2026-12-31
Marketing Start 2011-02-15

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 03781626
Hyphenated Format 0378-1626

Supplemental Identifiers

RxCUI
349434 349435
UPC
0303781640930 0303781626934
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 ANDA090547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1626-93)
source: ndc

Packages (1)

0378-1626-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1626-93)

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": "32d3b3c7-0c9c-4b78-833e-b2acf9745ce9", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0303781640930", "0303781626934"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["67c174da-41b8-4738-8a22-dd814b8e96b8"], "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 Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1626-93)", "package_ndc": "0378-1626-93", "marketing_start_date": "20110215"}], "brand_name": "Voriconazole", "product_id": "0378-1626_32d3b3c7-0c9c-4b78-833e-b2acf9745ce9", "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": "0378-1626", "generic_name": "voriconazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "50 mg/1"}], "application_number": "ANDA090547", "marketing_category": "ANDA", "marketing_start_date": "20110215", "listing_expiration_date": "20261231"}