voriconazole

Generic: voriconazole

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler sandoz inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

voriconazole 200 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5668
Product ID 0781-5668_4be02cb0-ecd6-4f37-b33c-69696402c20d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200265
Listing Expiration 2026-12-31
Marketing Start 2011-12-12

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 07815668
Hyphenated Format 0781-5668

Supplemental Identifiers

RxCUI
349434 349435
UPC
0307815668310 0307815667313
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 ANDA200265 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (0781-5668-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5668-10)
  • 10 BLISTER PACK in 1 CARTON (0781-5668-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5668-06)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0781-5668-31)
source: ndc

Packages (4)

0781-5668-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-5668-05) 0781-5668-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5668-10) 0781-5668-13 10 BLISTER PACK in 1 CARTON (0781-5668-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5668-06) 0781-5668-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-5668-31)

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": "4be02cb0-ecd6-4f37-b33c-69696402c20d", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0307815668310", "0307815667313"], "unii": ["JFU09I87TR"], "rxcui": ["349434", "349435"], "spl_set_id": ["e2b3c0b3-02a6-45c3-a8ea-05d210dc9108"], "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": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0781-5668-05)", "package_ndc": "0781-5668-05", "marketing_start_date": "20111212"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (0781-5668-10)", "package_ndc": "0781-5668-10", "marketing_start_date": "20111212"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0781-5668-13)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5668-06)", "package_ndc": "0781-5668-13", "marketing_start_date": "20111212"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0781-5668-31)", "package_ndc": "0781-5668-31", "marketing_start_date": "20111212"}], "brand_name": "voriconazole", "product_id": "0781-5668_4be02cb0-ecd6-4f37-b33c-69696402c20d", "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": "0781-5668", "generic_name": "voriconazole", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA200265", "marketing_category": "ANDA", "marketing_start_date": "20111212", "listing_expiration_date": "20261231"}