voriconazole

Generic: voriconazole

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

voriconazole 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-027
Product ID 71288-027_50d3f4f4-6ed7-4362-baaa-fe2a73c1ef88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214516
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

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 71288027
Hyphenated Format 71288-027

Supplemental Identifiers

RxCUI
351209
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 ANDA214516 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-027-30) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-027-30 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-027-30) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

voriconazole (10 mg/mL)

Linked Drug Pages (1)

Voriconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "50d3f4f4-6ed7-4362-baaa-fe2a73c1ef88", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["351209"], "spl_set_id": ["d962d459-254f-4b78-ae28-7d9ec5d4e4d5"], "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": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-027-30)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-027-30", "marketing_start_date": "20220509"}], "brand_name": "Voriconazole", "product_id": "71288-027_50d3f4f4-6ed7-4362-baaa-fe2a73c1ef88", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "71288-027", "generic_name": "Voriconazole", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA214516", "marketing_category": "ANDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}