Tavaborole

Product NDC
70771-1826
11-digit product format
707711826
Labeler code
70771
Product ID
70771-1826_b7ea9baf-cd2b-4430-a0cf-85945ce38a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tavaborole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA212294
Marketing category
ANDA
Marketing start
2023-04-24
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
IngredientStrength
TAVABOROLE43.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK124A4EUQ3
Rxcui1543177

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
79fe69fe-2d2a-4706-b33c-c00838ac4adeProduct name220240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1826-0Tavaborole1 in 1 CARTONSOLUTION12
70771-1826-0Tavaborole10 mL in 1 BOTTLE, WITH APPLICATORSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1826TAVABOROLE SOLUTION [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 2 package rows20241208_15bc62dc-4f5e-4d43-a125-d1f00bee84a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543177tavaborole 5 % Topical SolutionPSN15bc62dc-4f5e-4d43-a125-d1f00bee84a52
1543177tavaborole 43.5 MG/ML Topical SolutionSCD15bc62dc-4f5e-4d43-a125-d1f00bee84a52
1543177tavaborole 5 % Topical SolutionSY15bc62dc-4f5e-4d43-a125-d1f00bee84a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1826-0707711826001 BOTTLE, WITH APPLICATOR in 1 CARTON (70771-1826-0) / 10 mL in 1 BOTTLE, WITH APPLICATOR2023-04-24NoNoHistorical