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NDC 69238-1657-04 Tavaborole 43.5 mg/mL Details
Tavaborole 43.5 mg/mL
Tavaborole is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is TAVABOROLE.
MedlinePlus Drug Summary
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.
Related Packages: 69238-1657-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tavaborole Topical
Product Information
| NDC | 69238-1657 |
|---|---|
| Product ID | 69238-1657_84f7f3e4-e52f-4054-ad9c-d57fc99f52ce |
| Associated GPIs | 90156080002010 |
| GCN Sequence Number | 072716 |
| GCN Sequence Number Description | tavaborole SOL W/APPL 5 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 36997 |
| HICL Sequence Number | 041353 |
| HICL Sequence Number Description | TAVABOROLE |
| Brand/Generic | Generic |
| Proprietary Name | Tavaborole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tavaborole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 43.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | TAVABOROLE |
| Labeler Name | Amneal Pharmaceuticals NY LLC |
| Pharmaceutical Class | Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212256 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69238-1657-04 (69238165704)
| NDC Package Code | 69238-1657-4 |
|---|---|
| Billing NDC | 69238165704 |
| Package | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4) / 4 mL in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2020-11-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |