voriconazole

Generic: voriconazole

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 200 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-199
Product ID 16714-199_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206837
Marketing Start 2016-01-22
Marketing End 2027-04-30

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 16714199
Hyphenated Format 16714-199

Supplemental Identifiers

RxCUI
349434 349435
UPC
0316714198019 0316714199016
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)
source: ndc

Packages (1)

16714-199-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)

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": "45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0316714198019", "0316714199016"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["b38165a5-d8d4-4579-a49a-fbe92e764089"], "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": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-199-01)", "package_ndc": "16714-199-01", "marketing_end_date": "20270430", "marketing_start_date": "20160122"}], "brand_name": "Voriconazole", "product_id": "16714-199_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f", "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": "16714-199", "generic_name": "Voriconazole", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA206837", "marketing_category": "ANDA", "marketing_end_date": "20270430", "marketing_start_date": "20160122"}