voriconazole

Generic: voriconazole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 50 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-572
Product ID 68462-572_1c47b796-6b3e-4321-86f6-f51fbf9a39fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203503
Marketing Start 2015-09-04
Marketing End 2026-11-01

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 68462572
Hyphenated Format 68462-572

Supplemental Identifiers

RxCUI
349434 349435
UPC
0368462573303
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 ANDA203503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68462-572-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-572-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68462-572-90)
source: ndc

Packages (3)

68462-572-13 3 BLISTER PACK in 1 CARTON (68462-572-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK 68462-572-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-572-30) 68462-572-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-572-90)

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": "1c47b796-6b3e-4321-86f6-f51fbf9a39fb", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0368462573303"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["4cbac6ad-0faa-4181-a830-27a9f1536b7a"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68462-572-13)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-572-13", "marketing_end_date": "20261101", "marketing_start_date": "20150904"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-572-30)", "package_ndc": "68462-572-30", "marketing_end_date": "20261101", "marketing_start_date": "20150904"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-572-90)", "package_ndc": "68462-572-90", "marketing_end_date": "20261101", "marketing_start_date": "20150904"}], "brand_name": "voriconazole", "product_id": "68462-572_1c47b796-6b3e-4321-86f6-f51fbf9a39fb", "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": "68462-572", "generic_name": "voriconazole", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "50 mg/1"}], "application_number": "ANDA203503", "marketing_category": "ANDA", "marketing_end_date": "20261101", "marketing_start_date": "20150904"}