tavaborole

Generic: tavaborole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tavaborole
Generic Name tavaborole
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-467
Product ID 46708-467_0bf82467-4605-43ba-a217-cdba1946becd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212188
Listing Expiration 2026-12-31
Marketing Start 2025-02-18

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 46708467
Hyphenated Format 46708-467

Supplemental Identifiers

RxCUI
1543177
UPC
0346708467104
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 ANDA212188 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 43.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (46708-467-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

46708-467-04 1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPER 46708-467-10 1 BOTTLE, DROPPER in 1 CARTON (46708-467-10) / 10 mL in 1 BOTTLE, DROPPER

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": "0bf82467-4605-43ba-a217-cdba1946becd", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "upc": ["0346708467104"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["6da415c6-a9be-42bf-829f-e72ccc5fe3ba"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46708-467-04)  / 4 mL in 1 BOTTLE, DROPPER", "package_ndc": "46708-467-04", "marketing_start_date": "20250218"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (46708-467-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "46708-467-10", "marketing_start_date": "20250218"}], "brand_name": "Tavaborole", "product_id": "46708-467_0bf82467-4605-43ba-a217-cdba1946becd", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "46708-467", "generic_name": "Tavaborole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tavaborole", "active_ingredients": [{"name": "TAVABOROLE", "strength": "43.5 mg/mL"}], "application_number": "ANDA212188", "marketing_category": "ANDA", "marketing_start_date": "20250218", "listing_expiration_date": "20261231"}