voriconazole

Generic: voriconazole

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-830
Product ID 65841-830_7666344f-3ba8-4a08-a828-65b846868dc0
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 65841830
Hyphenated Format 65841-830

Supplemental Identifiers

RxCUI
349434 349435
UPC
0365841831016 0365841830019
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 ANDA206747 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-830-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65841-830-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65841-830-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65841-830-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65841-830-16)
  • 10 BLISTER PACK in 1 CARTON (65841-830-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-830-30)
source: ndc

Packages (6)

65841-830-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-830-01) 65841-830-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-830-05) 65841-830-06 30 TABLET, FILM COATED in 1 BOTTLE (65841-830-06) 65841-830-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-830-10) 65841-830-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-830-16) 65841-830-77 10 BLISTER PACK in 1 CARTON (65841-830-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-830-30)

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": "7666344f-3ba8-4a08-a828-65b846868dc0", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0365841831016", "0365841830019"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["bda70104-d84b-4d3f-9ca0-5f4f1ca816ad"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-830-01)", "package_ndc": "65841-830-01", "marketing_start_date": "20160525"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-830-05)", "package_ndc": "65841-830-05", "marketing_start_date": "20160525"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65841-830-06)", "package_ndc": "65841-830-06", "marketing_start_date": "20160525"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-830-10)", "package_ndc": "65841-830-10", "marketing_start_date": "20160525"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-830-16)", "package_ndc": "65841-830-16", "marketing_start_date": "20160525"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-830-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-830-30)", "package_ndc": "65841-830-77", "marketing_start_date": "20160525"}], "brand_name": "voriconazole", "product_id": "65841-830_7666344f-3ba8-4a08-a828-65b846868dc0", "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": "65841-830", "generic_name": "voriconazole", "labeler_name": "Zydus Lifesciences Limited", "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"}