Tavaborole
- Product NDC
- 46708-467
- 11-digit product format
- 467080467
- Labeler code
- 46708
- Product ID
- 46708-467_0bf82467-4605-43ba-a217-cdba1946becd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tavaborole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA212188
- Marketing category
- ANDA
- Marketing start
- 2025-02-18
- 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 |
|---|
| 46708-467-04 | Tavaborole | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 46708-467-04 | Tavaborole | 4 mL in 1 BOTTLE, DROPPER | SOLUTION | 4 | | 1 |
| 46708-467-10 | Tavaborole | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 1 |
| 46708-467-10 | Tavaborole | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-467 | TAVABOROLE SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250221_6da415c6-a9be-42bf-829f-e72ccc5fe3ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-467-04 | 46708046704 | 1 BOTTLE, DROPPER in 1 CARTON (46708-467-04) / 4 mL in 1 BOTTLE, DROPPER | 2025-02-18 | No | No | Current |
| 46708-467-10 | 46708046710 | 1 BOTTLE, DROPPER in 1 CARTON (46708-467-10) / 10 mL in 1 BOTTLE, DROPPER | 2025-02-18 | No | No | Current |