Clobetasol Propionate

Product NDC
70030-166
11-digit product format
700300166
Labeler code
70030
Product ID
70030-166_e9f5fdfb-9638-4bdc-b078-3de17f4b270c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
HyGen Pharmaceuticals, Inc.
Application
ANDA074222
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 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 productproduct70030-166IInactivated by FDA2026-10-05
excluded packagepackage70030-16670030-166-25IInactivated by FDA2026-10-05
excluded packagepackage70030-16670030-166-50IInactivated by FDA2026-10-05

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 · 57 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 packagepackage70030-166-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70030-166-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70030-166-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70030-166-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70030-166-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70030-166-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70030-166-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70030-166-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70030-166-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70030-166-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70030-166-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70030-166-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70030-166-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70030-166-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70030-166-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70030-166-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70030-166-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70030-166-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70030-166-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70030-166-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70030-166-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70030-166-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70030-166-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70030-166-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70030-166-508af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70030-166-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70030-166-50834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70030-166-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70030-166-501332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70030-166-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70030-166-50fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70030-166-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70030-166-5086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70030-166-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70030-166-50bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70030-166-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70030-166-508dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70030-166-258dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074222-001EMBELINECLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1995-12-06

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-0684e616aacf4f…
2026-08-18 06:07:402026-07A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-063f01610625f2…
2019-09-15 20:21 UTC2019-09A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074222-001EMBELINE0.05%SOLUTION / TOPICALAT1995-12-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074222-001EMBELINE0.05%SOLUTION / TOPICALAT1995-12-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074222-001EMBELINE0.05%SOLUTION / TOPICALAT1995-12-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074222-001EMBELINE0.05%SOLUTION / TOPICALAT1995-12-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074222-001EMBELINE0.05%SOLUTION / TOPICALAT1995-12-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074222-001EMBELINE0.05%SOLUTION / TOPICALATRS1995-12-06f41ea6bd6efb…

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 ZIP2022-06A074222-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074222-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074222-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074222-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074222-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074222-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074222-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A074222-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074222-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074222-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074222-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A074222-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074222-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074222-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074222-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074222-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074222-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074222-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074222-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074222-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074222-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074222-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074222-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074222-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074222-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074222-001AT1cb3db0bc1861…

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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70030-166-25Clobetasol Propionate1 in 1 CARTONSOLUTION11
70030-166-25Clobetasol Propionate25 mL in 1 BOTTLESOLUTION251
70030-166-50Clobetasol Propionate1 in 1 CARTONSOLUTION11
70030-166-50Clobetasol Propionate50 mL in 1 BOTTLESOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70030-166CLOBETASOL PROPIONATE SOLUTION [HYGEN PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20180324_86126839-2dee-45fd-9bf0-29578538743a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70030-166-25700300166251 in 1 CARTONHistorical
70030-166-50700300166501 in 1 CARTONHistorical