Clobetasol Propionate

Product NDC
50090-4146
11-digit product format
500904146
Labeler code
50090
Product ID
50090-4146_3128bb76-55ce-4533-9f92-276e49cda7f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA074392
Marketing category
ANDA
Marketing start
1996-09-30
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4146IInactivated by FDA2026-08-03
excluded packagepackage50090-414650090-4146-0IInactivated 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 · 30 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 packagepackage50090-4146-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4146-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4146-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4146-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4146-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4146-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4146-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4146-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4146-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4146-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4146-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4146-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4146-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4146-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4146-01332a3947898…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
A074392-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074392-001AB1

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 UTC2026-02A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074392-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB11996-09-30cb3db0bc1861…

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 UTC2026-02A074392-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074392-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074392-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074392-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074392-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074392-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074392-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074392-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074392-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074392-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074392-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074392-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074392-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074392-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074392-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074392-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074392-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074392-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074392-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074392-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074392-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A074392-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074392-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074392-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074392-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A074392-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A074392-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074392-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074392-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074392-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074392-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074392-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074392-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074392-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A074392-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A074392-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074392-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074392-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074392-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074392-001AB11cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4146-02023-01-30C16284748780-1f386c649-a701-0266-e053-dadaa90a7c1aCLOBETASOL PROPIONATE CREAM USP, 0.05% (Potency expressed as clobetasol propionate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4146-0Clobetasol Propionate30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4146CLOBETASOL PROPIONATE CREAM [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190226_30b09d9d-56da-4849-a97b-844975f0c795.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.2d4fa3a3-dc1c-4d3c-9959-4751e09d25be2025-07-08Adverse reactionsExact identifier
application applno (ANDA): 074392
application number: ANDA074392
Clobetasol PropionateCLOBETASOL PROPIONATEProficient Rx LPe0f7bc85-9c13-44df-9b37-c216ecfe3ffe2024-03-01Adverse reactionsExact identifier
application applno (ANDA): 074392
application number: ANDA074392

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN30b09d9d-56da-4849-a97b-844975f0c7952
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD30b09d9d-56da-4849-a97b-844975f0c7952
861495clobetasol propionate 0.05 % Topical CreamSY30b09d9d-56da-4849-a97b-844975f0c7952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4146-05009041460030 g in 1 TUBE (50090-4146-0) 30 g2019-02-150000-00-00NoNoCurrent