HYDROCORTISONE VALERATE

Product NDC
61919-010
11-digit product format
619190010
Labeler code
61919
Product ID
61919-010_9c9728d1-a5bd-556a-e053-2995a90a5994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE VALERATE
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA075666
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE VALERATE
Active strength
2 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-010IInactivated by FDA2026-08-17
excluded packagepackage61919-01061919-010-15IInactivated by FDA2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-010-15IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-010-15IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-010-15IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-010-15IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-010-15IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-010-15IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-010-15IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-010-15IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-010-15IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-010-15IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-010-15IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-010-15IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-010-15IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-010-15IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-010-15IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-010-15EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075666-001HYDROCORTISONE VALERATEHYDROCORTISONE VALERATE0.2%CREAM / TOPICAL2000-05-24

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICAL2000-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-243f01610625f2…
2019-09-15 20:21 UTC2019-09A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075666-001HYDROCORTISONE VALERATE0.2%CREAM / TOPICALAB2000-05-24e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075666-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075666-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075666-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075666-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075666-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075666-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075666-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075666-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075666-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075666-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075666-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075666-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075666-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075666-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075666-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075666-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075666-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075666-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075666-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075666-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075666-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075666-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075666-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075666-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075666-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075666-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075666-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075666-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075666-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075666-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075666-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075666-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075666-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075666-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075666-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075666-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075666-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075666-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075666-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075666-001AB1cb3db0bc1861…

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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-010-152023-01-30C16284748780-1f386c649-f844-0266-e053-dadaa90a7c1aHYDROCORTISONE VALERATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-010-15HYDROCORTISONE VALERATE15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-010-15GM - Gram61919-010e77286d2-4e2f-4116-b954-cd8db2f21ce512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE VALERATEACTIVE INGREDIENT68717P8FUZHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROCORTISONE VALERATE CREAM [DIRECT RX]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE VALERATE CREAM [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE VALERATE CREAM [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-010HYDROCORTISONE VALERATE CREAM [DIRECT RX]3Legacy NDC, 1 package rows20200121_f165db21-1f03-4f33-8383-196f6adda6e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370754hydrocortisone valerate 0.2 % Topical CreamPSNf165db21-1f03-4f33-8383-196f6adda6e33
1370754hydrocortisone valerate 2 MG/ML Topical CreamSCDf165db21-1f03-4f33-8383-196f6adda6e33
1370754hydrocortisone valerate 0.2 % Topical CreamSYf165db21-1f03-4f33-8383-196f6adda6e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-010-156191900101515 g in 1 TUBE (61919-010-15) 15 g2015-01-010000-00-00NoNoCurrent