desoximetasone

Product NDC: 45802-496
11-digit product format: 458020496
Labeler code: 45802
Product ID: 45802-496_3b8c8718-4be4-4a05-9cf0-f2f4430c675e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desoximetasone
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA077770
Marketing category: ANDA
Marketing start: 2015-05-14
Substance: DESOXIMETASONE
Active strength: 2.5 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 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
A077770-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2015-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077770-001	AB

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 · 42 observed 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	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077770-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077770-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077770-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077770-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077770-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077770-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077770-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077770-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077770-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077770-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077770-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077770-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077770-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077770-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077770-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077770-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077770-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077770-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077770-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077770-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077770-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077770-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077770-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077770-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077770-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077770-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077770-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077770-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077770-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077770-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077770-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077770-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077770-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077770-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077770-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077770-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077770-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077770-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077770-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077770-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESOXIMETASONE	2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4E07GXB7AU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197575	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
4025ed23-a591-4754-8dbb-4da18f49a3e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83e6065d-d4c9-f323-882e-7de38bb4d6ac	Product name	9	20200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7be	Product name	3	20190204
08e04f33-a0f6-279a-7d07-56df7c40d693	Product name	3	20180605
d67f22fb-500c-d680-0b1d-d0de623f55e7	Product name	7	20171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45802-496-14	desoximetasone	15 g in 1 TUBE	OINTMENT	15	7
45802-496-14	desoximetasone	1 in 1 CARTON	OINTMENT	1	7
45802-496-96	desoximetasone	1 in 1 CARTON	OINTMENT	1	7
45802-496-96	desoximetasone	60 g in 1 TUBE	OINTMENT	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-496-14	GM - Gram	45802-496	0f6a2541-235d-4161-b5a0-28f2235640aa	1	2015-05-05
45802-496-96	GM - Gram	45802-496	0228687a-a795-4ab2-9e33-4f43e166cb31	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESOXIMETASONE	ACTIVE INGREDIENT	4E07GXB7AU	DESOXIMETASONE OINTMENT [PERRIGO NEW YORK INC]	3
DESOXIMETASONE	ACTIVE MOIETY	4E07GXB7AU	DESOXIMETASONE OINTMENT [PERRIGO NEW YORK INC]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DESOXIMETASONE OINTMENT [PERRIGO NEW YORK INC]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DESOXIMETASONE OINTMENT [PERRIGO NEW YORK INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-496	DESOXIMETASONE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	7	Current NDC, Legacy NDC, 4 package rows	20240503_4025ed23-a591-4754-8dbb-4da18f49a3e3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	155e0a5f-183b-4517-88e3-22fef48d72c8	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	2a59a313-efd8-4377-bd41-caeeffa79775	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	dbaa172e-2f78-4c14-9abc-cc171b75115d	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770
desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4025ed23-a591-4754-8dbb-4da18f49a3e3	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770 ndc (product): 45802-496

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4E07GXB7AU	DESOXIMETASONE	382-67-2	DESOXIMETASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197575	desoximetasone 0.25 % Topical Ointment	PSN	155e0a5f-183b-4517-88e3-22fef48d72c8	106
197575	desoximetasone 0.0025 MG/MG Topical Ointment	SCD	155e0a5f-183b-4517-88e3-22fef48d72c8	106
197575	desoximetasone 0.25 % Topical Ointment	SY	155e0a5f-183b-4517-88e3-22fef48d72c8	106
197575	desoximetasone 0.25 % Topical Ointment	PSN	2a59a313-efd8-4377-bd41-caeeffa79775	103
197575	desoximetasone 0.25 % Topical Ointment	PSN	dbaa172e-2f78-4c14-9abc-cc171b75115d	103
197575	desoximetasone 0.0025 MG/MG Topical Ointment	SCD	2a59a313-efd8-4377-bd41-caeeffa79775	103
197575	desoximetasone 0.0025 MG/MG Topical Ointment	SCD	dbaa172e-2f78-4c14-9abc-cc171b75115d	103
197575	desoximetasone 0.25 % Topical Ointment	SY	2a59a313-efd8-4377-bd41-caeeffa79775	103
197575	desoximetasone 0.25 % Topical Ointment	SY	dbaa172e-2f78-4c14-9abc-cc171b75115d	103
197575	desoximetasone 0.25 % Topical Ointment	PSN	4025ed23-a591-4754-8dbb-4da18f49a3e3	7
197575	desoximetasone 0.0025 MG/MG Topical Ointment	SCD	4025ed23-a591-4754-8dbb-4da18f49a3e3	7
197575	desoximetasone 0.25 % Topical Ointment	SY	4025ed23-a591-4754-8dbb-4da18f49a3e3	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-496-14	45802049614	1 TUBE in 1 CARTON (45802-496-14) / 15 g in 1 TUBE	1 tube	2015-05-14	0000-00-00	No	No	Current
45802-496-96	45802049696	1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE	1 tube	2015-06-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desoximetasone Ointment USP, 0.25%	Bryant Ranch Prepack	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	106
Desoximetasone Ointment USP, 0.25%	Bryant Ranch Prepack	2024-03-12	HUMAN PRESCRIPTION DRUG LABEL	103
Desoximetasone Ointment USP, 0.25%	Bryant Ranch Prepack	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	103
Desoximetasone Ointment USP, 0.25%	Padagis Israel Pharmaceuticals Ltd	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	7