Clobetasol Propionate Cream

Product NDC
70512-028
Requested package NDC
70512-028-60
11-digit product format
705120028
Labeler code
70512
Product ID
70512-028_b8bc7e18-cd15-7cb2-e053-2a95a90a2f01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Sola Pharmaceuticals
Application
ANDA209974
Marketing category
ANDA
Marketing start
2019-02-04
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70512-02870512-028-60DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 12 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70512-02870512-028-60DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A209974-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17

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 UTC2026-02A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICAL2018-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209974-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-04-17cb3db0bc1861…

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 ZIP2022-06A209974-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209974-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209974-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209974-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209974-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209974-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209974-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A209974-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209974-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209974-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209974-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A209974-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A209974-001AB11ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209974-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209974-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A209974-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A209974-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209974-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209974-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209974-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209974-001AB11cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-028-60GM - Gram70512-028badaa1ff-9ce4-4ac3-8230-6318d93290f312019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70512-028-60705120028601 TUBE in 1 CARTON (70512-028-60) > 60 g in 1 TUBE1 tube2019-02-040000-00-00NoNoCurrent