voriconazole

Generic: voriconazole

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler amneal pharmaceuticals llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

voriconazole 40 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-913
Product ID 65162-913_b09170c8-4ca1-4e5e-9c29-cbb36a3f585d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205034
Listing Expiration 2027-12-31
Marketing Start 2013-11-29

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 65162913
Hyphenated Format 65162-913

Supplemental Identifiers

RxCUI
465355
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 ANDA205034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 75 mL in 1 BOTTLE (65162-913-22)
source: ndc

Packages (1)

65162-913-22 75 mL in 1 BOTTLE (65162-913-22)

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": "b09170c8-4ca1-4e5e-9c29-cbb36a3f585d", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["465355"], "spl_set_id": ["ed6624a9-0b73-4a21-bf13-a8add2081d02"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "75 mL in 1 BOTTLE (65162-913-22)", "package_ndc": "65162-913-22", "marketing_start_date": "20131129"}], "brand_name": "Voriconazole", "product_id": "65162-913_b09170c8-4ca1-4e5e-9c29-cbb36a3f585d", "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": "65162-913", "generic_name": "Voriconazole", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "40 mg/mL"}], "application_number": "ANDA205034", "marketing_category": "ANDA", "marketing_start_date": "20131129", "listing_expiration_date": "20271231"}