Tavaborole

Product NDC: 69238-1657
Requested package NDC: 69238-1657-4
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1657	69238-1657-4	D	Discontinued by firm		2026-09-09

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212256-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212256-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212256-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212256-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212256-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212256-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212256-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212256-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212256-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212256-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212256-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212256-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212256-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212256-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212256-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212256-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212256-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212256-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212256-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212256-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212256-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212256-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212256-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212256-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212256-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212256-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212256-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212256-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212256-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212256-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212256-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212256-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1657-4	ML - Milliliter	69238-1657	92e0f5be-f42e-4c6d-a896-ef9f6f5e501a	1	2021-03-02
69238-1657-6	ML - Milliliter	69238-1657	61bd74fb-0aee-43f7-b99f-dc0d871aac65	1	2021-03-02

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tavaborole	TAVABOROLE	Amneal Pharmaceuticals NY LLC	c7f19812-3811-4a3a-9909-43a7a7f134d4	2019-06-15	Adverse reactions	Exact identifier application applno (ANDA): 212256 application number: ANDA212256 ndc (package): 69238-1657-4 ndc (product): 69238-1657 ndc11 (package): 69238165704

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K124A4EUQ3	TAVABOROLE	174671-46-6	TAVABOROLE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tavaborole	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals, LLC	2019-06-15	HUMAN PRESCRIPTION DRUG LABEL	10