Tavaborole
- Product NDC
- 62332-467
- 11-digit product format
- 623320467
- Labeler code
- 62332
- Product ID
- 62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tavaborole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA212188
- Marketing category
- ANDA
- Marketing start
- 2020-10-23
- 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 |
|---|
| 62332-467-04 | Tavaborole | 4 mL in 1 BOTTLE, DROPPER | SOLUTION | 4 | | 8 |
| 62332-467-04 | Tavaborole | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 62332-467-10 | Tavaborole | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 62332-467-10 | Tavaborole | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-467 | TAVABOROLE SOLUTION [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20231216_22a6617b-d4b1-405e-901a-0b39a7b2837d.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 |
|---|
| 62332-467-04 | 62332046704 | 1 BOTTLE, DROPPER in 1 CARTON (62332-467-04) / 4 mL in 1 BOTTLE, DROPPER | 2020-10-23 | 0000-00-00 | No | No | Current |
| 62332-467-10 | 62332046710 | 1 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPER | 2020-10-23 | 0000-00-00 | No | No | Current |