voriconazole

Generic: voriconazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

voriconazole 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-892
Product ID 65862-892_a37376b7-2b29-4d4c-a747-96418f00df00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206837
Listing Expiration 2027-12-31
Marketing Start 2016-01-22

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 65862892
Hyphenated Format 65862-892

Supplemental Identifiers

RxCUI
349434 349435
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 ANDA206837 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-892-01)
  • 3 BLISTER PACK in 1 CARTON (65862-892-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-892-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-892-30)
source: ndc

Packages (4)

65862-892-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-892-01) 65862-892-03 3 BLISTER PACK in 1 CARTON (65862-892-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10) 65862-892-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-892-05) 65862-892-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-892-30)

Ingredients (1)

voriconazole (200 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": "a37376b7-2b29-4d4c-a747-96418f00df00", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["4fe672ff-2cef-4f88-ab85-5a4b586da20d"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-892-01)", "package_ndc": "65862-892-01", "marketing_start_date": "20160122"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-892-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10)", "package_ndc": "65862-892-03", "marketing_start_date": "20160122"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-892-05)", "package_ndc": "65862-892-05", "marketing_start_date": "20160122"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-892-30)", "package_ndc": "65862-892-30", "marketing_start_date": "20160122"}], "brand_name": "Voriconazole", "product_id": "65862-892_a37376b7-2b29-4d4c-a747-96418f00df00", "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": "65862-892", "generic_name": "Voriconazole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA206837", "marketing_category": "ANDA", "marketing_start_date": "20160122", "listing_expiration_date": "20271231"}