tavaborole

Generic: tavaborole

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tavaborole
Generic Name tavaborole
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-663
Product ID 62135-663_056ba459-06c7-c5c1-e063-6394a90a54bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211963
Listing Expiration 2026-12-31
Marketing Start 2021-02-03

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 62135663
Hyphenated Format 62135-663

Supplemental Identifiers

RxCUI
1543177
UPC
0362135663599
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 ANDA211963 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 43.5 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, DROPPER (62135-663-59)
source: ndc

Packages (1)

62135-663-59 10 mL in 1 BOTTLE, DROPPER (62135-663-59)

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": "056ba459-06c7-c5c1-e063-6394a90a54bc", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "upc": ["0362135663599"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["7fe75d38-80a0-444e-84bc-4087b45a791e"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (62135-663-59)", "package_ndc": "62135-663-59", "marketing_start_date": "20230908"}], "brand_name": "Tavaborole", "product_id": "62135-663_056ba459-06c7-c5c1-e063-6394a90a54bc", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "62135-663", "generic_name": "Tavaborole", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tavaborole", "active_ingredients": [{"name": "TAVABOROLE", "strength": "43.5 mg/mL"}], "application_number": "ANDA211963", "marketing_category": "ANDA", "marketing_start_date": "20210203", "listing_expiration_date": "20261231"}