Betamethasone Dipropionate

Product NDC
52959-124
11-digit product format
529590124
Labeler code
52959
Product ID
52959-124_cfb7782a-0363-4ea1-a7cc-259afa5336d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078930
Marketing category
ANDA
Marketing start
2008-09-23
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct52959-124IInactivated by FDA2026-11-10
excluded packagepackage52959-12452959-124-50IInactivated by FDA2026-11-10

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 · 44 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 packagepackage52959-124-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-124-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-124-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-124-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-124-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-124-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-124-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-124-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-124-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-124-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-124-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-124-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-124-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-124-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-124-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-124-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-124-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-124-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-124-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-124-50e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52959-124-509bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52959-124-50110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078930-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-23

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-23c2088c7a36db…
2026-09-14 22:38:342026-08A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-2384e616aacf4f…
2026-08-18 06:07:402026-07A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICAL2008-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2008-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2008-09-233f01610625f2…
2019-09-15 20:21 UTC2019-09A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2008-09-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2008-09-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078930-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALABRS2008-09-233a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078930-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078930-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078930-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078930-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078930-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078930-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078930-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078930-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078930-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078930-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078930-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078930-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078930-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078930-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078930-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078930-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078930-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078930-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078930-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078930-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078930-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078930-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078930-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078930-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078930-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078930-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078930-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078930-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078930-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078930-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078930-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078930-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078930-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078930-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078930-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078930-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078930-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-124-502019-11-13C16284748780-197449f38-d46f-f6ea-e053-dbdaa90aa703Betamethasone Dipropionate Cream, 0.05% (Augmented*)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-124-50Betamethasone Dipropionate50 g in 1 TUBECREAM503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-124-50GM - Gram52959-124e5d9160f-2ecb-41ce-8619-fca22ae1a72212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-124BETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 1 package rows20120104_c77f3c7e-e8ef-4169-9672-04599a63638a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNc77f3c7e-e8ef-4169-9672-04599a63638a3
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDc77f3c7e-e8ef-4169-9672-04599a63638a3
848176augmented betamethasone 0.05 % Topical CreamSYc77f3c7e-e8ef-4169-9672-04599a63638a3
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYc77f3c7e-e8ef-4169-9672-04599a63638a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-124-505295901245050 g in 1 TUBE50 gHistorical