Betamethasone Dipropionate

Product NDC
53002-8280
Requested package NDC
53002-8280-1
11-digit product format
530028280
Labeler code
53002
Product ID
53002-8280_bc8077f5-4fe5-42b9-98ad-8e39350ef86a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076592
Marketing category
ANDA
Marketing start
2006-09-28
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-828053002-8280-1IInactivated 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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A076592-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076592-001AB

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 06:07:402026-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093f01610625f2…
2019-09-15 20:21 UTC2019-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076592-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076592-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076592-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076592-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076592-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076592-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076592-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076592-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076592-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076592-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076592-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076592-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076592-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076592-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076592-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076592-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076592-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076592-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076592-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076592-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076592-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076592-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076592-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076592-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076592-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076592-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076592-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076592-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076592-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076592-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076592-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076592-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076592-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076592-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076592-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076592-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076592-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076592-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076592-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076592-001AB1e64feba35796…

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-01-30These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
2023-06-07These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
2023-01-30These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
2020-12-17These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
2020-01-31These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8280-1Betamethasone Dipropionate15 g in 1 TUBECREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8280BETAMETHASONE DIPROPIONATE CREAM [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_13c20c58-3911-4d96-be09-7184ee1f7d4f.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals, Inc.5683885d-461c-4e7e-bbe8-dc231d7061922026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepackf2c557ea-275b-4ab4-90f4-4003e022214d2025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepack0481ac0d-9220-472b-b3f2-af6e0bb6962d2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATENuCare Pharmaceuticals,Inc.84b37e6a-779e-5d43-e053-2a91aa0a16b72024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepack79256f36-adff-4628-abc5-cb25bdfdc19d2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPadagis Israel Pharmaceuticals Ltd7bd2646c-f34a-4824-8f66-c41e77db19d22023-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEProficient Rx LPf1be7c91-5408-4d31-8673-b691089aadce2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176augmented betamethasone 0.05 % Topical CreamSY13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY13c20c58-3911-4d96-be09-7184ee1f7d4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8280-15300282800115 g in 1 TUBE (53002-8280-1) 15 g2018-10-010000-00-00NoNoCurrent