CLOBETASOL PROPIONATE

Product NDC
71589-002
11-digit product format
715890002
Labeler code
71589
Product ID
71589-002_25b5f1b0-4830-4b84-be9a-a1415e67809e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aleor Dermaceuticals Limited
Application
ANDA211800
Marketing category
ANDA
Marketing start
2019-03-12
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#

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71589-002DDiscontinued by firm2026-08-17
excluded packagepackage71589-00271589-002-15DDiscontinued by firm2026-08-17
excluded packagepackage71589-00271589-002-30DDiscontinued by firm2026-08-17
excluded packagepackage71589-00271589-002-45DDiscontinued by firm2026-08-17
excluded packagepackage71589-00271589-002-60DDiscontinued by firm2026-08-17

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 2 · 75 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71589-002-45DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71589-002-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71589-002-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71589-002-15DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71589-002-45DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71589-002-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71589-002-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71589-002-15DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71589-002-45DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71589-002-60DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71589-002-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71589-002-15DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71589-002-45DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71589-002-60DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71589-002-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71589-002-15DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71589-002-45DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71589-002-60DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71589-002-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71589-002-15DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71589-002-45DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71589-002-60DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71589-002-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71589-002-15DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71589-002-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71589-002-15IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71589-002-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71589-002-45IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71589-002-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71589-002-15IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71589-002-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71589-002-45IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71589-002-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71589-002-15IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71589-002-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71589-002-45IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71589-002-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71589-002-15IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71589-002-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71589-002-45IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71589-002-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71589-002-15IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71589-002-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71589-002-45IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71589-002-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71589-002-15IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71589-002-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71589-002-45IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…

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
A211800-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211800-001AB

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 06:07:402026-07A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-043f01610625f2…
2019-09-15 20:21 UTC2019-09A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211800-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2019-03-04e64feba35796…

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 06:07:402026-07A211800-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211800-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211800-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211800-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211800-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211800-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211800-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211800-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211800-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211800-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211800-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211800-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211800-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211800-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211800-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211800-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211800-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211800-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211800-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211800-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211800-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211800-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211800-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211800-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211800-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211800-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211800-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211800-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211800-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211800-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211800-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211800-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211800-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211800-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211800-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211800-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211800-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211800-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211800-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211800-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71589-002-152025-02-27Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-302025-02-27Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-452025-02-27Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-602025-02-27Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-152024-01-30Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-302024-01-30Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-452024-01-30Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-602024-01-30Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATENuCare Pharmaceuticals, Inc.4524d04c-de48-6671-e063-6294a90a0e332025-12-04Adverse reactionsExact identifier
application applno (ANDA): 211800
application number: ANDA211800
Clobetasol PropionateCLOBETASOL PROPIONATEAlembic Pharmaceuticals Inc.fc3ac7b5-0cd5-4d31-97e4-b01c0f7158352025-03-28Adverse reactionsExact identifier
application applno (ANDA): 211800
application number: ANDA211800
Clobetasol PropionateCLOBETASOL PROPIONATEAlembic Pharmaceuticals Limited1a4331e1-5c79-44c3-a691-4b808a3bde972025-02-12Adverse reactionsExact identifier
application applno (ANDA): 211800
application number: ANDA211800

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71589-002-15715890002151 TUBE in 1 CARTON (71589-002-15) > 15 g in 1 TUBE1 tube2019-03-120000-00-00NoNoCurrent
71589-002-30715890002301 TUBE in 1 CARTON (71589-002-30) > 30 g in 1 TUBE1 tube2019-03-120000-00-00NoNoCurrent
71589-002-45715890002451 TUBE in 1 CARTON (71589-002-45) > 45 g in 1 TUBE1 tube2019-03-120000-00-00NoNoCurrent
71589-002-60715890002601 TUBE in 1 CARTON (71589-002-60) > 60 g in 1 TUBE1 tube2019-03-120000-00-00NoNoCurrent