voriconazole

Generic: voriconazole

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler mylan pharmaceuticals inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

voriconazole 40 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0935
Product ID 59762-0935_3ed9078b-c9be-42a0-a7b4-1072bf475363
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021630
Listing Expiration 2027-12-31
Marketing Start 2013-12-16

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 597620935
Hyphenated Format 59762-0935

Supplemental Identifiers

RxCUI
349434 349435 465355
UPC
0359762093530
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 NDA021630 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59762-0935-3) / 75 mL in 1 BOTTLE
source: ndc

Packages (1)

59762-0935-3 1 BOTTLE in 1 CARTON (59762-0935-3) / 75 mL in 1 BOTTLE

Ingredients (1)

voriconazole (40 mg/mL)

Linked Drug Pages (1)

Voriconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ed9078b-c9be-42a0-a7b4-1072bf475363", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0359762093530"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435", "465355"], "spl_set_id": ["b8de04a0-238d-4e0b-b0d9-7f7878b149d4"], "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": "1 BOTTLE in 1 CARTON (59762-0935-3)  / 75 mL in 1 BOTTLE", "package_ndc": "59762-0935-3", "marketing_start_date": "20131216"}], "brand_name": "Voriconazole", "product_id": "59762-0935_3ed9078b-c9be-42a0-a7b4-1072bf475363", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "59762-0935", "generic_name": "Voriconazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "40 mg/mL"}], "application_number": "NDA021630", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20131216", "listing_expiration_date": "20271231"}