voriconazole

Generic: voriconazole

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

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler lupin pharmaceuticals,inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

voriconazole 40 mg/mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-038
Product ID 43386-038_9b8865b7-cdc3-4505-b9ba-b3ab1bf909d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206799
Listing Expiration 2026-12-31
Marketing Start 2016-06-01

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 43386038
Hyphenated Format 43386-038

Supplemental Identifiers

RxCUI
465355
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 ANDA206799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE
source: ndc

Packages (1)

43386-038-60 1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE

Ingredients (1)

voriconazole (40 mg/mL)

Linked Drug Pages (1)

VORICONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9b8865b7-cdc3-4505-b9ba-b3ab1bf909d6", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["465355"], "spl_set_id": ["e37525e8-afb4-4583-b2de-af4aab9040d7"], "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": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (43386-038-60)  / 75 mL in 1 BOTTLE", "package_ndc": "43386-038-60", "marketing_start_date": "20160601"}], "brand_name": "VORICONAZOLE", "product_id": "43386-038_9b8865b7-cdc3-4505-b9ba-b3ab1bf909d6", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "43386-038", "generic_name": "voriconazole", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VORICONAZOLE", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "40 mg/mL"}], "application_number": "ANDA206799", "marketing_category": "ANDA", "marketing_start_date": "20160601", "listing_expiration_date": "20261231"}