Home NDC 46708-467 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 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 A212188-001 TAVABOROLE TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212188-001 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 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212188-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-10-21 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A212188-001 PC 2021-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212188-001 PC 2021-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212188-001 PC 2021-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212188-001 PC 2021-04-17 8869cabd3fbd…
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 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
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 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