Hydrocortisone Butyrate

Product NDC: 83148-012
11-digit product format: 831480012
Labeler code: 83148
Product ID: 83148-012_407bc1b6-5851-1b87-e063-6294a90a02da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone Butyrate
Dosage form: LOTION
Route: TOPICAL
Labeler: The J. Molner Company LLC
Application: ANDA209556
Marketing category: ANDA
Marketing start: 2023-11-06
Substance: HYDROCORTISONE BUTYRATE
Active strength: 1 mg/mL
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
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE BUTYRATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05RMF7YPWN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1370763	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
160c463e-80d2-4bca-8b7f-42279617e309	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
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
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83148-012-02	Hydrocortisone Butyrate	59 mL in 1 BOTTLE	LOTION	59	6
83148-012-02	Hydrocortisone Butyrate	1 in 1 CARTON	LOTION	1	6
83148-012-04	Hydrocortisone Butyrate	1 in 1 CARTON	LOTION	1	6
83148-012-04	Hydrocortisone Butyrate	118 mL in 1 BOTTLE	LOTION	118	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83148-012-02	ML - Milliliter	83148-012	7e9f117e-90b3-4442-92a8-70cafb81be63	1	2023-12-05
83148-012-04	ML - Milliliter	83148-012	eac96157-df62-4e02-abad-c0292e2cea00	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83148-012	HYDROCORTISONE BUTYRATE LOTION [THE J. MOLNER COMPANY LLC]	5	Current NDC, 4 package rows	20241009_160c463e-80d2-4bca-8b7f-42279617e309.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 · 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 ndc (product): 83148-012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1370763	hydrocortisone butyrate 0.1 % Topical Lotion	PSN	ce135638-e551-4bb0-bd2b-f97d381a8c7c	100
1370763	hydrocortisone butyrate 1 MG/ML Topical Lotion	SCD	ce135638-e551-4bb0-bd2b-f97d381a8c7c	100
1370763	hydrocortisone butyrate 0.1 % Topical Lotion	SY	ce135638-e551-4bb0-bd2b-f97d381a8c7c	100
1370763	hydrocortisone butyrate 0.1 % Topical Lotion	PSN	160c463e-80d2-4bca-8b7f-42279617e309	6
1370763	hydrocortisone butyrate 1 MG/ML Topical Lotion	SCD	160c463e-80d2-4bca-8b7f-42279617e309	6
1370763	hydrocortisone butyrate 0.1 % Topical Lotion	SY	160c463e-80d2-4bca-8b7f-42279617e309	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83148-012-02	83148001202	1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE	1 bottle	2023-11-06	No	No	Current
83148-012-04	83148001204	1 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLE	1 bottle	2023-11-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Butyrate	Bryant Ranch Prepack	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	100
Hydrocortisone Butyrate	The J. Molner Company LLC \| The J. Molner Company OU \| Ferndale Laboratories, Inc.	2025-10-06	HUMAN PRESCRIPTION DRUG LABEL	6