Tavaborole 43.5 mg/mL Solution
Other active recalls for Tavaborole (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Oxaborole Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Tavaborole topical solution is used to treat fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). Tavaborole topical solution is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
Read the full MedlinePlus article ↗- Tavaborole topical solution is used to treat a fungal infection of the toenails called onychomycosis. It works against the two fungi most commonly responsible — Trichophyton rubrum...
- Yes, 48 weeks — about 11 months — is a long treatment course, and I understand that can feel like a lot. But here's the thing: toenails grow very slowly, and the fungus lives deep...
- How long do I really need to use this for? That seems like a long time.
- The most common side effects are local — some skin peeling, redness, or mild irritation right where you apply it, and occasionally an ingrown toenail. These are usually manageable....
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tavaborole — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $8.79 | $35.18 / 4 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tavaborole 43.5 mg/mL 21922-0020-12 | Encube | 1 bottle | $3.490 | AB | Availability likely | — |
| Tavaborole 43.5 mg/mL 62135-0663-59 | Chartwell | 10 ml | $3.490 | AB | Availability likely | — |
| Tavaborole 43.5 mg/mL 72578-0102-04 | Viona | 1 bottle | $3.490 | AB | Availability likely | — |
| tavaborole 43.5 mg/mL 51862-0690-10 | Mayne | 1 bottle | $5.041 | AB | Discontinued | — |
| Tavaborole 43.5 mg/mL 46708-0467-04 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Tavaborole 43.5 mg/mL 62332-0467-04 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Tavaborole 43.5 mg/mL 69097-0686-34 | Cipla | 1 bottle | — | — | Discontinued | — |
| Tavaborole 43.5 mg/mLthis 69238-1657-04 | Amneal | 1 bottle | — | — | Discontinued | — |
| Tavaborole 43.5 mg/mL 70771-1826-00 | Zydus | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 69238-1657-04 You're viewing this | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4) / 4 mL in 1 BOTTLE, WITH APPLICATOR | — | — | 2020-11-28 | Discontinued by firm |
| 69238-1657-06 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-6) / 10 mL in 1 BOTTLE, WITH APPLICATOR | $3.49 / mL | $34.90 | 2020-11-28 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 69238-1657-04?
What NDC number is used to bill for this package of Tavaborole 43.5 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Tavaborole topical solution is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply tavaborole topical solution to affected toenails once daily for 48 weeks. Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. Tavaborole topical solution is for topical use only and not for oral, ophthalmic, or intravaginal use.
Apply tavaborole topical solution to affected toenails once daily for 48 weeks. (2) Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. (2) For topical use only.
(2) Not for oral, ophthalmic, or intravaginal use. (2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tavaborole topical solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution contains 43.5 mg (5% w/w) of tavaborole. Solution, 5%. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. (4)
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with tavaborole included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 791 subjects were treated with tavaborole. The most commonly reported adverse reactions are listed below (Table 1).
Table 1: Adverse Reactions Occurring in ≥1% of Tavaborole Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term Tavaborole N=791 n (%) Vehicle N=395 n (%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application site dermatitis 10 (1.3%) 0 (0%)
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of tavaborole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug product exposure: Hypersensitivity; contact allergy
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on tavaborole use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits.
Embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes.
The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Oral administration In an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6 to 19) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e. a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the MRHD based on AUC comparisons].
No developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the MRHD based on AUC comparisons). In an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7 to 19) to pregnant female rabbits. In the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole.
No drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the MRHD based on AUC comparisons). No embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the MRHD based on AUC comparisons). In an oral pre- and post-natal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).
In the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the MRHD based on AUC comparisons). Topical administration In a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6 to 28) to pregnant female rabbits. A dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution.
A decrease in fetal bodyweight was noted at 10% tavaborole solution. No drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the MRHD based on AUC comparisons). No embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the MRHD based on AUC comparisons).
8.2Lactation Risk Summary There is no information available on the presence of tavaborole in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of tavaborole to women who are breastfeeding. Tavaborole is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of tavaborole to a breastfed infant.
Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tavaborole and any potential…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on tavaborole use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits.
Embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes.
The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Oral administration In an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6 to 19) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e. a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the MRHD based on AUC comparisons].
No developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the MRHD based on AUC comparisons). In an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7 to 19) to pregnant female rabbits. In the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole.
No drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the MRHD based on AUC comparisons). No embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the MRHD based on AUC comparisons). In an oral pre- and post-natal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).
In the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the MRHD based on AUC comparisons). Topical administration In a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6 to 28) to pregnant female rabbits. A dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution.
A decrease in fetal bodyweight was noted at 10% tavaborole solution. No drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the MRHD based on AUC comparisons). No embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the MRHD based on AUC comparisons).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of tavaborole were established in patients 6 years of age and older. Use of tavaborole in these age groups is supported by evidence from adequate and well-controlled studies of tavaborole in adults with additional data from an open-label pharmacokinetics study of tavaborole in subjects 12 years to less than 17 years old [see Clinical Pharmacology (12.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials of 791 subjects who were exposed to tavaborole, 19% were 65 years of age and over, while 4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tavaborole is an oxaborole antifungal [see Clinical Pharmacology (12.4) ] .
12.2Pharmacodynamics At therapeutic doses, tavaborole is not expected to prolong QTc to any clinically relevant extent.
12.3Pharmacokinetics Tavaborole undergoes extensive metabolism. Renal excretion is the major route of elimination of the metabolites. In a clinical pharmacology trial of six healthy adult male volunteers who received a single topical application of 5% 14 C-tavaborole solution, tavaborole conjugates and metabolites were shown to be excreted primarily in the urine.
The pharmacokinetics (PK) of tavaborole was investigated in 24 adult subjects with distal subungual onychomycosis involving at least 4 toenails (including at least 1 great toenail) following a single-dose and a 2-week daily topical application of 200 μL of a 5% solution of tavaborole to all ten toenails and 2 mm of skin surrounding each toenail. Steady-state was achieved after 14 days of dosing. After a single-dose, the mean (± standard deviation) peak concentration (C max ) of tavaborole was 3.5 ± 2.3 ng/mL (n=21 with measurable concentrations, range 0.618 to 10.2 ng/mL, LLOQ=0.5 ng/mL), and the mean AUC last ± SD was 44.4 ± 25.5 ng*hr/mL (n=21).
After 2 weeks of daily dosing, the mean C max ± SD was 5.2 ± 3.5 ng/mL (n=24, range 1.5 to 12.8 ng/mL), and the mean AUC τ ± SD was 75.8 ± 44.5 ng*hr/mL. In another study PK of tavaborole was investigated in 22 subjects aged 12 years to less than 17 years with distal subungual onychomycosis involving at least 4 toenails (including at least 1 great toenail with at least 20% involvement) following once daily application of 5% solution of tavaborole to all ten toenails and 2 mm of skin surrounding each toenail for 29 days.
On Day 29, the mean ± SD C max was 5.9 ± 4.9 ng/mL (n=21 with measurable concentrations, range 1.0 to 16.4 ng/mL, LLOQ=0.5 ng/mL), and the mean ± SD AUC 0-24 was 76.0 ± 62.5 ng*hr/mL. Drug Interaction Studies In Vitro Studies In vitro studies have shown that tavaborole, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
12.4Microbiology Mechanism of Action The mechanism of action of tavaborole is inhibition of fungal protein synthesis. Tavaborole inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS). Activity in vitro and in clinical infections Tavaborole has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ] : Trichophyton rubrum Trichophyton mentagrophytes Mechanism of Resistance Trichophyton mentagrophytes and Trichophyton rubrum strains from isolates collected in the clinical trials have not demonstrated resistance following repeated exposure to tavaborole.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tavaborole is an oxaborole antifungal [see Clinical Pharmacology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Tavaborole Topical Solution, 5% is available as a clear, colorless solution free from visual foreign particulate matter filled 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 69238-1657-6 : One 10 cc bottle containing 10 mL of solution with one plastic wrapped glass pointed-tip dropper.
NDC 69238-1657-4 : One 6 cc bottle containing 4 mL of solution with one plastic wrapped glass pointed-tip dropper.
16.2Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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. The dropper assembly contains Dry Natural Rubber. Keep bottle tightly closed. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7 H 6 BFO 2 , the molecular weight is 151.93 and the structural formula is: Tavaborole is a white to off-white powder.
It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol (73.70% v/v), edetate calcium disodium, and propylene glycol.
Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information and Instructions for Use ) The patient should be told the following: The impact of nail polish or other cosmetic nail products on the efficacy of tavaborole has not been evaluated. Inform a health care professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling). Product is flammable.
Avoid use near heat or open flame. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 06-2019-00