Hydrocortisone

Product NDC: 52565-005
11-digit product format: 525650005
Labeler code: 52565
Product ID: 52565-005_4cc0d9e7-5f6b-4a18-819c-069b63695131
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: LOTION
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA203804
Marketing category: ANDA
Marketing start: 2018-07-27
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 25 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52565-005		I	Inactivated by FDA		2026-08-03
excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA		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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	52565-005		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52565-005	52565-005-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

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
A203804-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	LOTION / TOPICAL			2018-07-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	2018-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	2018-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	2018-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	2018-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	2018-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203804-001	HYDROCORTISONE	2.5%	LOTION / TOPICAL		2018-07-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203804-001	AT	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A203804-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203804-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203804-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203804-001	AT	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-005-60	2022-01-28	C162847	48780-1	d6a99b39-691f-a426-e053-dadaa90af4c2	HYDROCORTISONE LOTION USP, 2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52565-005-60	Hydrocortisone	59 mL in 1 BOTTLE	LOTION	59		1
52565-005-60	Hydrocortisone	1 in 1 CARTON	LOTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-005	HYDROCORTISONE LOTION [TELIGENT PHARMA, INC.]	1	Legacy NDC, 2 package rows	20180731_5aacab36-0130-dc7b-92a5-dd288588d1d8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197785	hydrocortisone 2.5 % Topical Lotion	PSN	5aacab36-0130-dc7b-92a5-dd288588d1d8	1
197785	hydrocortisone 25 MG/ML Topical Lotion	SCD	5aacab36-0130-dc7b-92a5-dd288588d1d8	1
197785	hydrocortisone 2.5 % Topical Lotion	SY	5aacab36-0130-dc7b-92a5-dd288588d1d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-005-60	52565000560	1 BOTTLE in 1 CARTON (52565-005-60) > 59 mL in 1 BOTTLE	1 bottle	2018-07-27	0000-00-00	No	No	Current