Home NDC 70771-1826 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212294-001 TAVABOROLE TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212294-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212294-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2023-04-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K124A4EUQ3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1543177 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1826-0 Tavaborole 1 in 1 CARTON SOLUTION 1 2 70771-1826-0 Tavaborole 10 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1826 TAVABOROLE SOLUTION [ZYDUS LIFESCIENCES LIMITED] 2 Current NDC, 2 package rows 20241208_15bc62dc-4f5e-4d43-a125-d1f00bee84a5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70771-1826-0 70771182600 1 BOTTLE, WITH APPLICATOR in 1 CARTON (70771-1826-0) / 10 mL in 1 BOTTLE, WITH APPLICATOR 2023-04-24 No No Current