Halobetasol Propionate

Product NDC
72162-2331
11-digit product format
721622331
Labeler code
72162
Product ID
72162-2331_6f2da325-8423-4d36-b4b6-88272fbaa607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077123
Marketing category
ANDA
Marketing start
2008-08-04
Substance
HALOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A077123-001HALOBETASOL PROPIONATEHALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077123-001AB

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 UTC2026-02A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077123-001HALOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2004-12-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077123-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077123-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077123-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077123-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077123-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077123-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077123-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077123-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077123-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077123-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077123-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077123-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077123-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077123-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077123-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077123-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077123-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077123-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077123-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077123-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077123-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077123-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077123-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077123-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077123-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077123-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077123-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077123-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077123-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077123-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077123-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077123-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077123-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077123-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077123-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077123-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077123-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077123-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077123-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077123-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Halobetasol Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91A0K1TY3ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
977990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e408184b-0545-4728-9f95-90d8cdec544aAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2331-2Halobetasol Propionate1 in 1 CARTONCREAM12
72162-2331-2Halobetasol Propionate50 g in 1 TUBECREAM502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2331-2GM - Gram72162-2331da18f964-4bdb-437c-aa83-feba306f57d112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2331HALOBETASOL PROPIONATE CREAM [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20240619_e408184b-0545-4728-9f95-90d8cdec544a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halobetasol PropionateHALOBETASOL PROPIONATEBryant Ranch Prepacke408184b-0545-4728-9f95-90d8cdec544a2026-04-23Adverse reactionsExact identifier
application applno (ANDA): 077123
application number: ANDA077123
ndc (product): 72162-2331
Halobetasol PropionateHALOBETASOL PROPIONATEPadagis Israel Pharmaceuticals Ltddf26430c-8182-4d03-a254-06d913de4c952022-12-01Adverse reactionsExact identifier
application applno (ANDA): 077123
application number: ANDA077123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977990halobetasol propionate 0.05 % Topical CreamPSNe408184b-0545-4728-9f95-90d8cdec544a2
977990halobetasol propionate 0.5 MG/ML Topical CreamSCDe408184b-0545-4728-9f95-90d8cdec544a2
977990halobetasol propionate 0.05 % Topical CreamSYe408184b-0545-4728-9f95-90d8cdec544a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2331-2721622331021 TUBE in 1 CARTON (72162-2331-2) / 50 g in 1 TUBE1 tube2024-06-18NoNoCurrent