Clobetasol Propionate

Product NDC
0574-2063
11-digit product format
005742063
Labeler code
0574
Product ID
0574-2063_d69443af-9e55-4975-94bd-3873a982e770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Paddock Laboratories, LLC.
Application
ANDA090898
Marketing category
ANDA
Marketing start
2015-01-02
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0574-2063DDiscontinued by firm2026-08-03
excluded packagepackage0574-20630574-2063-02DDiscontinued by firm2026-08-03
excluded packagepackage0574-20630574-2063-04DDiscontinued by firm2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0574-2063-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0574-2063-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0574-2063-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0574-2063-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0574-2063-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0574-2063-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0574-2063-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0574-2063-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0574-2063-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0574-2063-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0574-2063-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0574-2063-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0574-2063-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0574-2063-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0574-2063-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0574-2063-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0574-2063-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0574-2063-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0574-2063-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0574-2063-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0574-2063-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0574-2063-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0574-2063-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0574-2063-04557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090898-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%SPRAY / TOPICAL2011-06-16

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 UTC2026-02A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090898-001CLOBETASOL PROPIONATE0.05%SPRAY / TOPICALAT2011-06-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090898-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090898-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090898-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090898-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090898-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090898-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090898-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090898-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090898-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090898-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090898-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090898-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090898-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090898-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090898-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090898-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090898-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090898-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090898-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090898-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090898-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A090898-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090898-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090898-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090898-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A090898-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090898-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090898-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090898-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090898-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090898-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090898-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090898-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090898-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090898-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090898-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090898-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090898-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090898-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090898-001AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2063-02ML - Milliliter0574-206382c3a9f7-6fa6-4a00-8f8d-18116d20ed9112015-01-05
0574-2063-04ML - Milliliter0574-206385419a98-3c37-45c6-8a90-a34551add06612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7
UNDECYLENIC ACIDINACTIVE INGREDIENTK3D86KJ24NCLOBETASOL PROPIONATE SPRAY [PADDOCK LABORATORIES, LLC]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-2063-02005742063021 BOTTLE, SPRAY in 1 CARTON (0574-2063-02) > 59 mL in 1 BOTTLE, SPRAY2015-01-020000-00-00NoNoCurrent
0574-2063-04005742063041 BOTTLE, SPRAY in 1 CARTON (0574-2063-04) > 125 mL in 1 BOTTLE, SPRAY2015-01-020000-00-00NoNoCurrent