TAVABOROLE
- Product NDC
- 69097-686
- 11-digit product format
- 690970686
- Labeler code
- 69097
- Product ID
- 69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TAVABOROLE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA212224
- Marketing category
- ANDA
- Marketing start
- 2021-02-18
- 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 |
|---|
| 69097-686-34 | TAVABOROLE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 69097-686-34 | TAVABOROLE | 4 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 4 | | 3 |
| 69097-686-37 | TAVABOROLE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 69097-686-37 | TAVABOROLE | 10 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-686 | TAVABOROLE SOLUTION [CIPLA USA INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240110_37004451-0345-4e00-96be-f05db600fb9f.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 |
|---|
| 69097-686-34 | 69097068634 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-34) > 4 mL in 1 BOTTLE, WITH APPLICATOR | 2021-02-18 | 0000-00-00 | No | No | Current |
| 69097-686-37 | 69097068637 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 10 mL in 1 BOTTLE, WITH APPLICATOR | 2021-02-18 | 0000-00-00 | No | No | Current |