Halobetasol propionate

Product NDC: 51862-606
11-digit product format: 518620606
Labeler code: 51862
Product ID: 51862-606_8012775b-1c49-4293-98ab-b7d7f8c08253
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Halobetasol propionate
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: NDA210566
Marketing category: NDA
Marketing start: 2019-02-04
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	51862-606		D	Discontinued by firm	2026-08-03
excluded package	package	51862-606	51862-606-02	D	Discontinued by firm	2026-08-03
excluded package	package	51862-606	51862-606-33	D	Discontinued by firm	2026-08-03
excluded package	package	51862-606	51862-606-50	D	Discontinued by firm	2026-08-03

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 · 46 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	51862-606-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-606-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-606-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-606-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-606-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-606-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-606-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-606-50	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-606-50	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-606-50	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-606-50	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-606-33	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	51862-606-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-606-50	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-606-33	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51862-606-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51862-606-33	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
51862-606-02	2026-01-14	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-33	2026-01-14	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-50	2026-01-14	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-02	2024-07-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-33	2024-07-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-50	2024-07-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-02	2024-01-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-33	2024-01-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. HALOBETASOL PROPIONATE topical foam Initial U.S. Approval: 1990
51862-606-50	2024-01-30	These highlights do not include all the information needed to use HALOBETASOL PROPIONATE topical foam safely and effectively. See full prescribing information for HALOBETASOL PROPIONATE topical foam. 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
51862-606-02	GM - Gram	51862-606	aec3b97b-20fe-4f51-acdd-f63417dac5e3	1	2019-02-13
51862-606-50	GM - Gram	51862-606	62f421bc-c15a-48d2-9e9d-9b52316b880c	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-606	HALOBETASOL PROPIONATE AEROSOL, FOAM [MAYNE PHARMA]	7	Legacy NDC	20230815_d6994177-be9f-4c59-8330-e841c8239a0e.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
51862-606-02	51862060602	2 CANISTER in 1 CARTON (51862-606-02) > 50 g in 1 CANISTER	2 canister	2019-02-04	0000-00-00	No	No	Current
51862-606-33	51862060633	1 CANISTER in 1 CARTON (51862-606-33) > 17 g in 1 CANISTER	1 canister	2019-02-04	0000-00-00	No	No	Current
51862-606-50	51862060650	1 CANISTER in 1 CARTON (51862-606-50) > 50 g in 1 CANISTER	1 canister	2019-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halobetasol propionate - Mayne Pharma \| Pharmasol Corporation	Mayne Pharma \| Pharmasol Corporation	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	7