tavaborole

Generic: tavaborole

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tavaborole
Generic Name tavaborole
Labeler cipla usa inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

tavaborole 43.5 mg/mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-686
Product ID 69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212224
Listing Expiration 2026-12-31
Marketing Start 2021-02-18

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 69097686
Hyphenated Format 69097-686

Supplemental Identifiers

RxCUI
1543177
UPC
0369097686345 0369097686376
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 ANDA212224 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 43.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 10 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

69097-686-37 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 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": "01ca8568-cd52-42e0-87b8-2eea35a77364", "openfda": {"nui": ["N0000191279", "N0000000150", "M0002832"], "upc": ["0369097686345", "0369097686376"], "unii": ["K124A4EUQ3"], "rxcui": ["1543177"], "spl_set_id": ["37004451-0345-4e00-96be-f05db600fb9f"], "pharm_class_cs": ["Boron Compounds [CS]"], "pharm_class_epc": ["Oxaborole Antifungal [EPC]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37)  / 10 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "69097-686-37", "marketing_start_date": "20210218"}], "brand_name": "TAVABOROLE", "product_id": "69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364", "dosage_form": "SOLUTION", "pharm_class": ["Boron Compounds [CS]", "Oxaborole Antifungal [EPC]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "69097-686", "generic_name": "TAVABOROLE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAVABOROLE", "active_ingredients": [{"name": "TAVABOROLE", "strength": "43.5 mg/mL"}], "application_number": "ANDA212224", "marketing_category": "ANDA", "marketing_start_date": "20210218", "listing_expiration_date": "20261231"}