Halobetasol Propionate

Product NDC
52565-073
11-digit product format
525650073
Labeler code
52565
Product ID
52565-073_35da6f20-71cb-4679-8dca-bfd561b4c9fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209978
Marketing category
ANDA
Marketing start
2018-03-20
Marketing end
0000-00-00
Substance
HALOBETASOL PROPIONATE
Active strength
1 mg/g
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 productproduct52565-073IInactivated by FDA2026-08-11
excluded packagepackage52565-07352565-073-15IInactivated by FDA2026-08-11
excluded packagepackage52565-07352565-073-51IInactivated by FDA2026-08-11

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 · 45 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 packagepackage52565-073-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52565-073-51d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-073-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-073-51f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-073-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-073-512ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-073-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-073-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-073-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-073-51cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-073-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-073-51cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-073-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-073-51302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-073-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-073-51ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-073-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-073-510efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-073-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-073-51ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-073-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-073-51367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-073-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-073-51557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-073-158af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-073-518af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-073-15834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-073-51834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-073-151332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-073-511332a3947898…d4bfe170f9cd…

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
A209978-001HALOBETASOL PROPIONATEHALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209978-001AB

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 · 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 UTC2026-02A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL2018-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209978-001HALOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-03-20cb3db0bc1861…

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 ZIP2022-06A209978-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209978-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209978-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209978-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209978-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209978-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209978-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209978-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209978-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209978-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209978-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209978-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209978-001AB1ea99ee380514…
2023-05-13 08:27 UTC2023-05A209978-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209978-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209978-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209978-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209978-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209978-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209978-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3Product name120151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2Product name120140508
ee2f33ab-1561-3107-e994-434cb17b4d06Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-073-15Halobetasol Propionate15 g in 1 TUBEOINTMENT152
52565-073-15Halobetasol Propionate1 in 1 CARTONOINTMENT12
52565-073-51Halobetasol Propionate50 g in 1 TUBEOINTMENT502
52565-073-51Halobetasol Propionate1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-073-15GM - Gram52565-073b1c3f6d3-f9bb-46a4-a9e1-0ddca78a84e412018-05-09
52565-073-51GM - Gram52565-073fe67d7a7-2d47-44ce-8208-28081297f11b12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-073HALOBETASOL PROPIONATE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_102dd731-6f73-458f-9d95-9cdf14a5df06.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halobetasol PropionateHALOBETASOL PROPIONATEEncube Ethicals, Inc.d4f03a79-3d5e-4a39-8ab0-8ebd3d804e392026-06-29Adverse reactionsExact identifier
application applno (ANDA): 209978
application number: ANDA209978

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSN102dd731-6f73-458f-9d95-9cdf14a5df062
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCD102dd731-6f73-458f-9d95-9cdf14a5df062
977978halobetasol propionate 0.05 % Topical OintmentSY102dd731-6f73-458f-9d95-9cdf14a5df062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-073-15525650073151 TUBE in 1 CARTON (52565-073-15) > 15 g in 1 TUBE1 tube2018-03-200000-00-00NoNoCurrent
52565-073-51525650073511 TUBE in 1 CARTON (52565-073-51) > 50 g in 1 TUBE1 tube2018-03-200000-00-00NoNoCurrent