TAVABOROLE

Product NDC: 69097-686
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

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	69097-686	69097-686-34	D	Discontinued by firm		2026-08-17

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212224-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212224-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212224-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212224-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212224-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212224-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212224-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212224-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212224-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212224-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212224-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212224-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212224-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212224-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212224-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212224-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212224-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212224-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212224-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212224-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212224-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212224-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212224-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212224-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212224-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212224-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212224-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212224-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212224-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212224-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212224-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212224-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212224-001	AB	1	`cb3db0bc1861…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
37004451-0345-4e00-96be-f05db600fb9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
79fe69fe-2d2a-4706-b33c-c00838ac4ade	Product name	2	20240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-686-37	ML - Milliliter	69097-686	1c81adb2-016f-4266-954d-f5701554899e	1	2021-03-02

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAVABOROLE	TAVABOROLE	Cipla USA Inc.	37004451-0345-4e00-96be-f05db600fb9f	2025-12-19	Adverse reactions	Exact identifier application applno (ANDA): 212224 application number: ANDA212224 ndc (product): 69097-686

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543177	tavaborole 5 % Topical Solution	PSN	37004451-0345-4e00-96be-f05db600fb9f	3
1543177	tavaborole 43.5 MG/ML Topical Solution	SCD	37004451-0345-4e00-96be-f05db600fb9f	3
1543177	tavaborole 5 % Topical Solution	SY	37004451-0345-4e00-96be-f05db600fb9f	3

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
69097-686-37	69097068637	1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 10 mL in 1 BOTTLE, WITH APPLICATOR	2021-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TAVABOROLE	Cipla USA Inc. \| Encube Ethicals Private Limited \| AZICO BIOPHORE INDIA PRIVATE LIMITED	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	3