Desoximetasone

Product NDC: 0472-0478
Requested package NDC: 0472-0478-60
11-digit product format: 004720478
Labeler code: 0472
Product ID: 0472-0478_29695558-45f1-48cc-89b1-4063d16e2a5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desoximetasone
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA205082
Marketing category: ANDA
Marketing start: 2016-03-31
Marketing end: 2026-07-31
Substance: DESOXIMETASONE
Active strength: 2.5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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	0472-0478	0472-0478-60	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
A205082-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB		2015-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205082-001	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	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205082-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2015-09-04	`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	A205082-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205082-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205082-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205082-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205082-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205082-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205082-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205082-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205082-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205082-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205082-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205082-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205082-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205082-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205082-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205082-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205082-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205082-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205082-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205082-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205082-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205082-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205082-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205082-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205082-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205082-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205082-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205082-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205082-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205082-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205082-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205082-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205082-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205082-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205082-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205082-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205082-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205082-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205082-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205082-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
0472-0478-15	Desoximetasone	1 in 1 CARTON	CREAM	1	7
0472-0478-15	Desoximetasone	15 g in 1 TUBE	CREAM	15	7
0472-0478-60	Desoximetasone	1 in 1 CARTON	CREAM	1	7
0472-0478-60	Desoximetasone	60 g in 1 TUBE	CREAM	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0478-15	GM - Gram	0472-0478	d310a737-0b3e-41b3-b8ab-184b3777d584	1	2016-05-16
0472-0478-60	GM - Gram	0472-0478	77d558c0-321d-4c92-94c3-cc6eafcb3675	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0478	DESOXIMETASONE CREAM [ACTAVIS PHARMA, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20200403_1c472cf0-bf2c-45bb-be8b-e1137794de71.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
Desoximetasone	DESOXIMETASONE	Proficient Rx LP	f30b6fcc-43bc-4d65-9c3b-8d6ca780a024	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205082 application number: ANDA205082

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
197574	desoximetasone 0.25 % Topical Cream	PSN	1c472cf0-bf2c-45bb-be8b-e1137794de71	7
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	1c472cf0-bf2c-45bb-be8b-e1137794de71	7
197574	desoximetasone 0.25 % Topical Cream	SY	1c472cf0-bf2c-45bb-be8b-e1137794de71	7
197574	desoximetasone 0.25 % Topical Cream	PSN	03214a63-5ec2-49c5-9847-908bdfb06df8	5
197574	desoximetasone 0.25 % Topical Cream	PSN	24f3d9cc-5376-4d8e-b113-9e675bd0ceec	5
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	03214a63-5ec2-49c5-9847-908bdfb06df8	5
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	24f3d9cc-5376-4d8e-b113-9e675bd0ceec	5
197574	desoximetasone 0.25 % Topical Cream	SY	03214a63-5ec2-49c5-9847-908bdfb06df8	5
197574	desoximetasone 0.25 % Topical Cream	SY	24f3d9cc-5376-4d8e-b113-9e675bd0ceec	5
197574	desoximetasone 0.25 % Topical Cream	PSN	f30b6fcc-43bc-4d65-9c3b-8d6ca780a024	4
197574	desoximetasone 2.5 MG/ML Topical Cream	SCD	f30b6fcc-43bc-4d65-9c3b-8d6ca780a024	4
197574	desoximetasone 0.25 % Topical Cream	SY	f30b6fcc-43bc-4d65-9c3b-8d6ca780a024	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0478-60	00472047860	1 TUBE in 1 CARTON (0472-0478-60) / 60 g in 1 TUBE	1 tube	2016-03-31	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desoximetasone Cream USP, 0.25%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Desoximetasone Cream USP, 0.25%	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Desoximetasone Cream USP, 0.25%	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	5
Desoximetasone Cream USP, 0.25%	Actavis Pharma, Inc.	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	7