HYDROCORTISONE BUTYRATE

Product NDC: 51862-159
Requested package NDC: 51862-159-04
11-digit product format: 518620159
Labeler code: 51862
Product ID: 51862-159_5cc0fa38-756a-4fe1-9e2e-789273ed8014
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCORTISONE BUTYRATE
Dosage form: LOTION
Route: TOPICAL
Labeler: Mayne Pharma Inc.
Application: ANDA209556
Marketing category: ANDA
Marketing start: 2019-11-29
Marketing end: 0000-00-00
Substance: HYDROCORTISONE BUTYRATE
Active strength: 1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51862-159	51862-159-04	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A209556-001	HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB		2017-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209556-001	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 · 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	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209556-001	HYDROCORTISONE BUTYRATE	0.1%	LOTION / TOPICAL	AB	2017-11-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209556-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209556-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209556-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209556-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209556-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209556-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209556-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209556-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209556-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209556-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209556-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209556-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209556-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209556-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209556-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209556-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209556-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209556-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209556-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209556-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209556-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209556-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209556-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209556-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209556-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209556-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209556-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209556-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209556-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209556-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209556-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209556-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209556-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209556-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209556-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209556-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209556-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209556-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209556-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209556-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-159-04	ML - Milliliter	51862-159	9ae21a7c-f6f5-4d20-9145-58bd9a70ace0	1	2019-11-12

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Evesse	HYDROCORTISONE BUTYRATE	Perfero Pharma, Inc.	988b5524-2947-4862-9d5b-e8b7fec5fd9a	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209556 application number: ANDA209556
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	Bryant Ranch Prepack	ce135638-e551-4bb0-bd2b-f97d381a8c7c	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209556 application number: ANDA209556
Hydrocortisone Butyrate	HYDROCORTISONE BUTYRATE	The J. Molner Company LLC	160c463e-80d2-4bca-8b7f-42279617e309	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209556 application number: ANDA209556

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
05RMF7YPWN	HYDROCORTISONE BUTYRATE	13609-67-1	HYDROCORTISONE BUTYRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-159-04	51862015904	1 BOTTLE in 1 CARTON (51862-159-04) > 118 mL in 1 BOTTLE	1 bottle	2019-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE BUTYRATE	Mayne Pharma Inc. \| Teligent Pharma, Inc.	2019-10-24	HUMAN PRESCRIPTION DRUG LABEL	1