Home NDC 69238-1657 Tavaborole
Product NDC 69238-1657
11-digit product format 692381657
Labeler code 69238
Product ID 69238-1657_3a89e994-c11b-4867-a1a0-a4e97767fe2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tavaborole
Dosage form SOLUTION
Route TOPICAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212256
Marketing category ANDA
Marketing start 2020-11-28
Marketing end 0000-00-00
Substance TAVABOROLE
Active strength 44 mg/mL
Pharmacologic classes Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 A212256-001 TAVABOROLE TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25
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 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2020-11-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212256-001 TAVABOROLE 5% SOLUTION / TOPICAL 2020-11-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tavaborole 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1657 TAVABOROLE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] 7 Legacy NDC 20230608_c7f19812-3811-4a3a-9909-43a7a7f134d4.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69238-1657-4 69238165704 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4) > 4 mL in 1 BOTTLE, WITH APPLICATOR 2020-11-28 0000-00-00 No No Current 69238-1657-6 69238165706 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-6) > 10 mL in 1 BOTTLE, WITH APPLICATOR 2020-11-28 0000-00-00 No No Current