voriconazole

Generic: voriconazole

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler solco healthcare u.s., llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

voriconazole 200 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-378
Product ID 43547-378_50fab275-8f53-4dce-8c76-7c51fa170fcd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206654
Listing Expiration 2026-12-31
Marketing Start 2016-10-28

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 43547378
Hyphenated Format 43547-378

Supplemental Identifiers

RxCUI
349434 349435
UPC
0343547377038 0343547378035
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 ANDA206654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (43547-378-03)
  • 500 TABLET, COATED in 1 BOTTLE (43547-378-50)
source: ndc

Packages (2)

43547-378-03 30 TABLET, COATED in 1 BOTTLE (43547-378-03) 43547-378-50 500 TABLET, COATED in 1 BOTTLE (43547-378-50)

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": "50fab275-8f53-4dce-8c76-7c51fa170fcd", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0343547377038", "0343547378035"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["f6a1a792-141b-42e8-8bd1-884e4408eb8a"], "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": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (43547-378-03)", "package_ndc": "43547-378-03", "marketing_start_date": "20161028"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (43547-378-50)", "package_ndc": "43547-378-50", "marketing_start_date": "20161028"}], "brand_name": "Voriconazole", "product_id": "43547-378_50fab275-8f53-4dce-8c76-7c51fa170fcd", "dosage_form": "TABLET, 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": "43547-378", "generic_name": "Voriconazole", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA206654", "marketing_category": "ANDA", "marketing_start_date": "20161028", "listing_expiration_date": "20261231"}