HYDROCORTISONE BUTYRATE

Product NDC
68682-392
Requested package NDC
68682-392-02
11-digit product format
686820392
Labeler code
68682
Product ID
68682-392_2f38330f-dede-a2af-e063-6294a90a1a94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA022076
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-06-08
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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68682-39268682-392-02DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022076-001LOCOIDHYDROCORTISONE BUTYRATE0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LOTION / TOPICALRLD2007-05-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022076-001LOCOID0.1%LOTION / TOPICALRLD2007-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022076-001LOCOID0.1%LOTION / TOPICALABRLD, RS2007-05-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022076-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022076-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022076-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022076-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022076-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022076-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022076-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022076-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022076-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022076-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022076-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022076-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022076-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022076-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022076-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022076-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022076-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022076-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022076-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022076-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022076-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022076-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022076-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022076-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022076-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022076-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022076-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022076-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022076-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022076-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022076-00179818772025-01-23Drug product2011-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022076-00179818772025-01-23Drug product2011-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022076-00179818772025-01-23Drug product2011-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022076-00179818772025-01-23Drug product2011-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022076-00179818772025-01-23Drug product2011-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022076-00179818772025-01-23Drug product2011-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022076-00179818772025-01-23Drug product2011-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022076-00179818772025-01-23Drug product2011-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022076-00179818772025-01-23Drug product2011-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022076-00179818772025-01-23Drug product2011-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022076-00179818772025-01-23Drug product2011-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022076-00179818772025-01-23Drug product2011-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022076-00179818772025-01-23Drug product2011-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022076-00179818772025-01-23Drug product2011-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022076-00173784052026-12-19Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022076-00179818772025-01-23Drug product2011-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022076-00173784052026-12-19Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022076-00179818772025-01-23Drug product2011-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022076-00173784052026-12-19Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022076-00179818772025-01-23Drug product2011-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022076-00173784052026-12-19Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022076-00179818772025-01-23Drug product2011-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022076-00173784052026-12-19Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022076-00179818772025-01-23Drug product2011-08-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N022076-00173784052026-12-19Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022076-00179818772025-01-23Drug product2011-08-1887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022076-00173784052026-12-19Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022076-00179818772025-01-23Drug product2011-08-185aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022076-00173784052026-12-19Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022076-00179818772025-01-23Drug product2011-08-188869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022076-00173784052026-12-19Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022076-00179818772025-01-23Drug product2011-08-18c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022076-00173784052026-12-19Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022076-00179818772025-01-23Drug product2011-08-183f01610625f2…
2019-12-14 00:12 UTC2019-12N022076-00173784052026-12-19Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022076-00179818772025-01-23Drug product2011-08-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N022076-00173784052026-12-19Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022076-00179818772025-01-23Drug product2011-08-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N022076-00173784052026-12-19Drug productea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022076-00179818772025-01-23Drug product2011-08-186a51e52b5d6a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-392-02HYDROCORTISONE BUTYRATE1 in 1 CARTONLOTION15
68682-392-02HYDROCORTISONE BUTYRATE59 mL in 1 BOTTLELOTION595
68682-392-04HYDROCORTISONE BUTYRATE118 mL in 1 BOTTLELOTION1185
68682-392-04HYDROCORTISONE BUTYRATE1 in 1 CARTONLOTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-392-02ML - Milliliter68682-392b269e692-0af6-446a-8449-99dc07ce333812018-08-13
68682-392-04ML - Milliliter68682-39207602d47-fb3f-4873-8c72-bb1981921a2d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-392HYDROCORTISONE BUTYRATE LOTION [OCEANSIDE PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250303_dde66620-657b-4b30-bd30-4bb6e83612cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370763hydrocortisone butyrate 0.1 % Topical LotionPSNdde66620-657b-4b30-bd30-4bb6e83612cb5
1370763hydrocortisone butyrate 1 MG/ML Topical LotionSCDdde66620-657b-4b30-bd30-4bb6e83612cb5
1370763hydrocortisone butyrate 0.1 % Topical LotionSYdde66620-657b-4b30-bd30-4bb6e83612cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-392-02686820392021 BOTTLE in 1 CARTON (68682-392-02) / 59 mL in 1 BOTTLE1 bottle2018-06-080000-00-00NoNoCurrent