LEXETTE

Product NDC: 51862-618
11-digit product format: 518620618
Labeler code: 51862
Product ID: 51862-618_8aa1f819-c81f-4af1-aaa7-353df3203ff6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: halobetasol propionate
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: ANDA215266
Marketing category: ANDA
Marketing start: 2025-08-08
Substance: HALOBETASOL PROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 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
A215266-001	HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RS	2023-08-11

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
2026-02-19 14:30 UTC	2026-02	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB		2023-08-11	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215266-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RS	2023-08-11	`a50c72e98297…`

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	A215266-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215266-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215266-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215266-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215266-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215266-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215266-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215266-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215266-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215266-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215266-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215266-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215266-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215266-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215266-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215266-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215266-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215266-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215266-001	AB	1	`9b2671bbb829…`

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	A215266-001	PC	2024-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215266-001	PC	2024-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215266-001	PC	2024-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215266-001	PC	2024-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215266-001	PC	2024-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215266-001	PC	2024-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215266-001	PC	2024-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215266-001	PC	2024-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215266-001	PC	2024-06-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215266-001	PC	2024-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215266-001	PC	2024-06-24	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: LEXETTE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOBETASOL PROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
91A0K1TY3Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2047646	Internal RxNorm lookup
2106585	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
8aa1f819-c81f-4af1-aaa7-353df3203ff6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6	Product name	2	20260220
9314f950-fe47-4276-b1f9-66d9d4a64eae	Product name	1	20220217
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
0bc08e12-b8ed-4802-abab-926d5509afb3	Product name	1	20210513
608e9379-3a63-4bf4-b035-b393ae8faa97	Product name	1	20190214
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3	Product name	1	20151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2	Product name	1	20140508
ee2f33ab-1561-3107-e994-434cb17b4d06	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51862-618-50	LEXETTE	1 in 1 CARTON	AEROSOL, FOAM	1		1
51862-618-50	LEXETTE	50 g in 1 CANISTER	AEROSOL, FOAM	50		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-618-50	GM - Gram	51862-618	037a896b-f910-4c84-a8e4-a3ab2cd7b8ad	1	2025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEXETTE	HALOBETASOL PROPIONATE	Mayne Pharma	8aa1f819-c81f-4af1-aaa7-353df3203ff6	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215266 application number: ANDA215266 ndc (product): 51862-618
Halobetasol propionate	HALOBETASOL PROPIONATE	Mayne Pharma	24c41e6d-a314-4984-b45f-e5aa1fffa9b6	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215266 application number: ANDA215266

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2047646	halobetasol propionate 0.05 % Topical Foam	PSN	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2106585	LEXETTE 0.05 % Topical Foam	PSN	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2106585	halobetasol propionate 0.5 MG/ML Topical Foam [Lexette]	SBD	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2047646	halobetasol propionate 0.5 MG/ML Topical Foam	SCD	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2047646	halobetasol propionate 0.05 % Topical Foam	SY	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2106585	Lexette 0.05 % Topical Foam	SY	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1
2106585	Lexette 0.5 MG/ML Topical Foam	SY	8aa1f819-c81f-4af1-aaa7-353df3203ff6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51862-618-50	51862061850	1 CANISTER in 1 CARTON (51862-618-50) / 50 g in 1 CANISTER	1 canister	2025-08-08	No	No	Current