Tavaborole
- Product NDC
- 21922-020
- 11-digit product format
- 219220020
- Labeler code
- 21922
- Product ID
- 21922-020_10a126f9-ec1b-44d2-8611-3d6660a53ae8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TAVABOROLE topical solution, 5%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA211297
- Marketing category
- ANDA
- Marketing start
- 2020-10-19
- 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 |
|---|
| 21922-020-12 | Tavaborole | 10 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 10 | | 7 |
| 21922-020-12 | Tavaborole | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-020 | TAVABOROLE (TAVABOROLE TOPICAL SOLUTION, 5%) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241218_050f5d10-5591-426e-9020-6516b3363304.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 21922-020-12 | 21922002012 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATOR | 2020-10-19 | 0000-00-00 | No | No | Current |