voriconazole

Generic: voriconazole

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

voriconazole 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6596
Product ID 0904-6596_8a78756d-636c-4537-9cfd-52075f11c06a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206747
Listing Expiration 2027-12-31
Marketing Start 2016-05-25

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 09046596
Hyphenated Format 0904-6596

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6596-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6596-04 30 BLISTER PACK in 1 CARTON (0904-6596-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "8a78756d-636c-4537-9cfd-52075f11c06a", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["349435"], "spl_set_id": ["49dcf3ae-6d6b-46fe-a88e-ec65f2de332e"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6596-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6596-04", "marketing_start_date": "20160525"}], "brand_name": "voriconazole", "product_id": "0904-6596_8a78756d-636c-4537-9cfd-52075f11c06a", "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": "0904-6596", "generic_name": "voriconazole", "labeler_name": "Major Pharmaceuticals", "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": "20160525", "listing_expiration_date": "20271231"}