Clobetasol Propionate

Product NDC
60432-133
11-digit product format
604320133
Labeler code
60432
Product ID
60432-133_4c83eaeb-bc3b-4b2e-a17e-29e3bea6eb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA075205
Marketing category
ANDA
Marketing start
1998-11-13
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60432-133DDiscontinued by firm2026-08-17
excluded packagepackage60432-13360432-133-25DDiscontinued by firm2026-08-17
excluded packagepackage60432-13360432-133-50DDiscontinued by firm2026-08-17

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 · 45 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-133-25DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-133-50DDiscontinued by firmd630ba8d3edf…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 packagepackage60432-133-50IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-133-25IInactivated 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 packagepackage60432-133-50IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-133-25IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A075205-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13

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 06:07:402026-07A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-133f01610625f2…
2019-09-15 20:21 UTC2019-09A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICALAT1998-11-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075205-001CLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1998-11-13e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075205-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075205-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075205-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075205-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075205-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075205-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075205-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A075205-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075205-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075205-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075205-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A075205-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075205-001AT1ea99ee380514…

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
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-133-25ML - Milliliter60432-13393d2adaa-b109-4a83-b3b6-7f75361704ea12012-07-24
60432-133-50ML - Milliliter60432-1332e0a7bc2-358c-4253-a9ff-bb45085c818612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31CLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31CLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302CLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-133CLOBETASOL PROPIONATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4Legacy NDC20181114_b8c0d9e3-498c-4721-bbc9-c1450b56ba14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN8cfa527c-69c5-4722-8246-c3b4ce591a5f1
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD8cfa527c-69c5-4722-8246-c3b4ce591a5f1
861487clobetasol propionate 0.05 % Topical SolutionSY8cfa527c-69c5-4722-8246-c3b4ce591a5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60432-133-25604320133251 BOTTLE, WITH APPLICATOR in 1 CARTON (60432-133-25) > 25 mL in 1 BOTTLE, WITH APPLICATOR1998-11-130000-00-00NoNoCurrent
60432-133-50604320133501 BOTTLE, WITH APPLICATOR in 1 CARTON (60432-133-50) > 50 mL in 1 BOTTLE, WITH APPLICATOR1998-11-130000-00-00NoNoCurrent