Tavaborole
- Product NDC
- 62135-663
- 11-digit product format
- 621350663
- Labeler code
- 62135
- Product ID
- 62135-663_056ba459-06c7-c5c1-e063-6394a90a54bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tavaborole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA211963
- Marketing category
- ANDA
- Marketing start
- 2021-02-03
- Substance
- TAVABOROLE
- Active strength
- 43.5 mg/mL
- Pharmacologic classes
- Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tavaborole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TAVABOROLE | 43.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K124A4EUQ3 |
| Rxcui | 1543177 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-663-59 | Tavaborole | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-663 | TAVABOROLE SOLUTION [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20230916_7fe75d38-80a0-444e-84bc-4087b45a791e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-663-59 | 62135066359 | 10 mL in 1 BOTTLE, DROPPER (62135-663-59) | 10 ml | 2023-09-08 | No | No | Historical |