tavaborole (51862-690) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name tavaborole

Generic Name tavaborole

Labeler mayne pharma commercial llc

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer

Mayne Pharma Commercial LLC

Identifiers & Regulatory

Product NDC 51862-690

Product ID 51862-690_12ed0433-3ec5-f721-e063-6294a90adc2b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211297

Listing Expiration 2026-12-31

Marketing Start 2021-02-01

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 51862690

Hyphenated Format 51862-690

Supplemental Identifiers

RxCUI

1543177

UPC

0351862690107

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 ANDA211297 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

43.5 mg/mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tavaborole topical solution, 5% is a clear, colorless solution supplied in an amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly. Tavaborole topical solution, 5% is supplied in the following presentations: NDC 51862-690-10: One bottle containing 10 mL of solution with one glass pointed-tip dropper. The Packaging of This Product Contains Dry Natural Rubber. 16.2 Storage and Handling Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children.
PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label NDC 51862-690-10 Tavaborole Topical Solution, 5% For Topical Use Only Not for oral, ophthalmic, or intravaginal use Rx Only 10 mL mayne pharma tavaborole-06

source: label

Packages (0)

No package records.

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": "12ed0433-3ec5-f721-e063-6294a90adc2b", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "upc": ["0351862690107"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["7ad9dc39-7501-4db5-a935-d9be8eea30a6"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "tavaborole", "product_id": "51862-690_12ed0433-3ec5-f721-e063-6294a90adc2b", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "51862-690", "generic_name": "tavaborole", "labeler_name": "Mayne Pharma Commercial LLC", "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": "20210201", "listing_expiration_date": "20261231"}