tavaborole

Generic: tavaborole

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

Drug Facts

Product Profile

Brand Name tavaborole
Generic Name tavaborole
Labeler viona pharmaceuticals inc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-102
Product ID 72578-102_266f7bbc-b540-4681-8144-cbb823f34f0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212294
Listing Expiration 2026-12-31
Marketing Start 2023-04-24

Pharmacologic Class

Established (EPC)
oxaborole antifungal [epc]
Mechanism of Action
protein synthesis inhibitors [moa]
Chemical Structure
boron compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578102
Hyphenated Format 72578-102

Supplemental Identifiers

RxCUI
1543177
UNII
K124A4EUQ3
NUI
N0000191279 N0000000150 M0002832

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 tavaborole (source: ndc)
Generic Name tavaborole (source: ndc)
Application Number ANDA212294 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 43.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-102-04) / 10 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

72578-102-04 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-102-04) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

tavaborole (43.5 mg/mL)

Linked Drug Pages (1)

Tavaborole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "266f7bbc-b540-4681-8144-cbb823f34f0e", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["c13610c8-c57a-4519-b37d-eb4fbdcec398"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-102-04)  / 10 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "72578-102-04", "marketing_start_date": "20230424"}], "brand_name": "Tavaborole", "product_id": "72578-102_266f7bbc-b540-4681-8144-cbb823f34f0e", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "72578-102", "generic_name": "Tavaborole", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tavaborole", "active_ingredients": [{"name": "TAVABOROLE", "strength": "43.5 mg/mL"}], "application_number": "ANDA212294", "marketing_category": "ANDA", "marketing_start_date": "20230424", "listing_expiration_date": "20261231"}