Home NDC 69097-686-34 TAVABOROLE
Product NDC 69097-686
Requested package NDC 69097-686-34
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 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 A212224-001 TAVABOROLE TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-09
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 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL AB 2021-02-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212224-001 TAVABOROLE 5% SOLUTION / TOPICAL 2021-02-09 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 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
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.
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