tavaborole

Generic: tavaborole topical solution, 5%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tavaborole
Generic Name tavaborole topical solution, 5%
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-020
Product ID 21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211297
Listing Expiration 2026-12-31
Marketing Start 2020-10-19

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 21922020
Hyphenated Format 21922-020

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 topical solution, 5% (source: ndc)
Application Number ANDA211297 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 43.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

21922-020-12 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 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": "10a126f9-ec1b-44d2-8611-3d6660a53ae8", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["050f5d10-5591-426e-9020-6516b3363304"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12)  / 10 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "21922-020-12", "marketing_start_date": "20201019"}], "brand_name": "Tavaborole", "product_id": "21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "21922-020", "generic_name": "TAVABOROLE topical solution, 5%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tavaborole", "active_ingredients": [{"name": "TAVABOROLE", "strength": "43.5 mg/mL"}], "application_number": "ANDA211297", "marketing_category": "ANDA", "marketing_start_date": "20201019", "listing_expiration_date": "20261231"}