Clobetasol Propionate Cream USP, 0.05%

Product NDC
68071-2671
11-digit product format
680712671
Labeler code
68071
Product ID
68071-2671_dbfe7b1d-6794-a6d8-e053-2a95a90a8e53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream USP, 0.05%
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212982
Marketing category
ANDA
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68071-2671IInactivated by FDA2026-08-03
excluded packagepackage68071-267168071-2671-3IInactivated 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 · 18 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2671-3IInactivated by FDAd630ba8d3edf…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 packagepackage68071-2671-3IInactivated 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 packagepackage68071-2671-3IInactivated 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 packagepackage68071-2671-3IInactivated 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 packagepackage68071-2671-3IInactivated 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 packagepackage68071-2671-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2671-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2671-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2671-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A212982-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212982-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12020-08-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212982-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB1RS2020-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212982-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212982-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212982-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212982-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212982-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212982-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212982-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212982-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212982-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212982-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212982-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212982-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212982-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212982-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212982-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212982-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212982-001AB114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212982-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212982-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212982-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A212982-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212982-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212982-001AB11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212982-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212982-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212982-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212982-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212982-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212982-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212982-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A212982-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A212982-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212982-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212982-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212982-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212982-001AB11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212982-001AB11a50c72e98297…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2671-32025-01-30C16284748780-12cef2736-814d-d83d-e063-dadaa90ab31fRx only FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2671-3Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2671CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220407_dbfe408a-ceb1-241a-e053-2a95a90a4d90.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Encube Ethicals, Inc.bcb76b4b-194d-4cb3-b3ed-26b911df1a112026-07-09Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE USP, 0.05%A-S Medication Solutionsd40ea303-9eba-4750-955d-6bb005882fb52026-01-06Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE USP, 0.05%A-S Medication Solutions98b23b99-fab4-49fb-b070-758fb030e9bb2025-12-04Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Bryant Ranch Prepacke9af15cc-7795-44e8-b294-0576309818242025-10-22Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%REMEDYREPACK INC.61f63eec-ecf3-4979-adab-f26eb8f29d652025-10-02Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Bryant Ranch Prepack29113d5e-1570-4fc5-9ce6-a00230e4377e2025-09-16Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05%CLOBETASOL PROPIONATE CREAM 0.05%Preferred Pharmaceuticals Inc.1917a2a1-1591-4383-8466-ae12988b209f2025-08-01Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEDIRECT RXcc716dab-b535-8b51-e053-2995a90a8f162025-01-20Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%CLOBETASOL PROPIONATE CREAM USP, 0.05%Northstar Rx LLC2a356447-46d2-40cc-b850-f387982c517a2024-09-09Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982
Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05%CLOBETASOL PROPIONATE CREAM, 0.05%Proficient Rx LP6f52ac0f-4028-4733-9ef6-e5ce5468b3842024-08-01Adverse reactionsExact identifier
application applno (ANDA): 212982
application number: ANDA212982

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.05 % Topical CreamSYdbfe408a-ceb1-241a-e053-2a95a90a4d902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2671-36807126710330 g in 1 TUBE (68071-2671-3) 30 g2022-04-060000-00-00NoNoCurrent