Hydrocortisone Butyrate

Product NDC
52565-087
Requested package NDC
52565-087-04
11-digit product format
525650087
Labeler code
52565
Product ID
52565-087_a0963357-1034-43ee-81bb-9c249fa29de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE BUTYRATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209556
Marketing category
ANDA
Marketing start
2017-11-21
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52565-08752565-087-04IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A209556-001HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209556-001AB

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 UTC2026-02A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-213f01610625f2…
2019-09-15 20:21 UTC2019-09A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209556-001HYDROCORTISONE BUTYRATE0.1%LOTION / TOPICALAB2017-11-21cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209556-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209556-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209556-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209556-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209556-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209556-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209556-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209556-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209556-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209556-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209556-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209556-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209556-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209556-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209556-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209556-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209556-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209556-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209556-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209556-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209556-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209556-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209556-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209556-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209556-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209556-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209556-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209556-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209556-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209556-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209556-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209556-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209556-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209556-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209556-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209556-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209556-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209556-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209556-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209556-001AB1cb3db0bc1861…

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-087-02Hydrocortisone Butyrate59 mL in 1 BOTTLELOTION592
52565-087-02Hydrocortisone Butyrate1 in 1 CARTONLOTION12
52565-087-04Hydrocortisone Butyrate1 in 1 CARTONLOTION12
52565-087-04Hydrocortisone Butyrate118 mL in 1 BOTTLELOTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-087-02ML - Milliliter52565-0872ada8c3c-6a15-41bd-af2c-b7656802445012018-03-08
52565-087-04ML - Milliliter52565-087568f1546-4980-43a8-a809-2f64c671906912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-087HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) LOTION [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_97d35248-b28b-18b0-98a6-2d93476fb4a3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvesseHYDROCORTISONE BUTYRATEPerfero Pharma, Inc.988b5524-2947-4862-9d5b-e8b7fec5fd9a2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209556
application number: ANDA209556
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEBryant Ranch Prepackce135638-e551-4bb0-bd2b-f97d381a8c7c2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209556
application number: ANDA209556
Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEThe J. Molner Company LLC160c463e-80d2-4bca-8b7f-42279617e3092025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209556
application number: ANDA209556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370763hydrocortisone butyrate 0.1 % Topical LotionPSN97d35248-b28b-18b0-98a6-2d93476fb4a32
1370763hydrocortisone butyrate 1 MG/ML Topical LotionSCD97d35248-b28b-18b0-98a6-2d93476fb4a32
1370763hydrocortisone butyrate 0.1 % Topical LotionSY97d35248-b28b-18b0-98a6-2d93476fb4a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-087-04525650087041 BOTTLE in 1 CARTON (52565-087-04) > 118 mL in 1 BOTTLE1 bottle2017-11-210000-00-00NoNoCurrent