LEXETTE

Product NDC: 51862-604
11-digit product format: 518620604
Labeler code: 51862
Product ID: 51862-604_7d4081b7-f8bd-459e-b671-958a44e9cf22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Halobetasol propionate
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: NDA210566
Marketing category: NDA
Marketing start: 2019-04-23
Marketing end: 0000-00-00
Substance: HALOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51862-604		D	Discontinued by firm	2026-08-11
excluded package	package	51862-604	51862-604-02	D	Discontinued by firm	2026-08-11
excluded package	package	51862-604	51862-604-33	D	Discontinued by firm	2026-08-11
excluded package	package	51862-604	51862-604-50	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-604-33	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-604-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-604-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-604-33	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-604-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-604-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-604-33	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-604-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-604-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-604-33	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-604-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-604-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-604-33	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-604-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-604-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-604-33	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-604-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-604-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-604-33	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-604-50	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-604-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-604-33	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-604-50	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-604-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-604-33	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-604-50	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-604-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-604-33	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-604-50	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-604-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-604-33	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-604-50	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-604-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51862-604-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N210566-001	LEXETTE	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2018-05-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210566-001	10857159	2036-11-30		Drug product	2020-12-11
N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29
N210566-001	10857159*PED	2037-05-30		Pediatric extension

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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210566-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210566-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210566-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	NPP	2024-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	NPP	2024-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	NPP	2024-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	NPP	2024-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	NPP	2024-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	NPP	2024-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	NPP	2024-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	NPP	2024-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	NPP	2024-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210566-001	NPP	2024-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210566-001	NPP	2024-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210566-001	NPP	2024-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210566-001	NDF	2021-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210566-001	NPP	2024-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210566-001	NDF	2021-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210566-001	NDF	2021-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210566-001	NDF	2021-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210566-001	NDF	2021-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210566-001	NDF	2021-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210566-001	NDF	2021-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210566-001	NDF	2021-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210566-001	NDF	2021-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	NPP	2024-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	NPP	2024-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	NPP	2024-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	NPP	2024-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	NPP	2024-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210566-001	NPP	2024-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210566-001	NPP	2024-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210566-001	NPP	2024-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210566-001	NPP	2024-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210566-001	NPP	2024-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210566-001	NPP	2024-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210566-001	NPP	2024-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210566-001	NPP	2024-08-18	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51862-604-02	2026-01-14	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-33	2026-01-14	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-50	2026-01-14	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-02	2024-07-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-33	2024-07-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-50	2024-07-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-02	2024-01-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-33	2024-01-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990
51862-604-50	2024-01-30	These highlights do not include all the information needed to use LEXETTE topical foam safely and effectively. See full prescribing information for LEXETTE topical foam. LEXETTE ® (halobetasol propionate) topical foam Initial U.S. Approval: 1990

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-604-02	GM - Gram	51862-604	7b69c9ed-6361-420d-bc19-616bfebc2f04	1	2019-05-02
51862-604-50	GM - Gram	51862-604	2e44f9d8-02a7-4786-8e6e-f5df72f51c54	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-604	LEXETTE (HALOBETASOL PROPIONATE) AEROSOL, FOAM [MAYNE PHARMA]	6	Legacy NDC	20230816_d5d0d307-37ad-4714-ba3f-5343672bc0e7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
91A0K1TY3Z	HALOBETASOL PROPIONATE	66852-54-8	HALOBETASOL PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-604-02	51862060402	2 CANISTER in 1 CARTON (51862-604-02) > 50 g in 1 CANISTER	2 canister	2019-04-23	0000-00-00	No	No	Current
51862-604-33	51862060433	1 CANISTER in 1 CARTON (51862-604-33) > 17 g in 1 CANISTER	1 canister	2019-04-23	0000-00-00	No	No	Current
51862-604-50	51862060450	1 CANISTER in 1 CARTON (51862-604-50) > 50 g in 1 CANISTER	1 canister	2019-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEXETTE - Mayne Pharma \| Pharmasol Corporation	Mayne Pharma \| Pharmasol Corporation	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	6