Home NDC 45802-129 Halobetasol Propionate
Product NDC 45802-129
11-digit product format 458020129
Labeler code 45802
Product ID 45802-129_4f3d068f-2393-41c4-9d14-47106cd5c6a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
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 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077123-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077123-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077123-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Halobetasol Propionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOBETASOL PROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 91A0K1TY3Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977990 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-129-32 Halobetasol Propionate 50 g in 1 TUBE CREAM 50 6 45802-129-32 Halobetasol Propionate 1 in 1 CARTON CREAM 1 6 45802-129-35 Halobetasol Propionate 1 in 1 CARTON CREAM 1 6 45802-129-35 Halobetasol Propionate 15 g in 1 TUBE CREAM 15 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HALOBETASOL PROPIONATE ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 Halobetasol ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 STEARETH-21 INACTIVE INGREDIENT 53J3F32P58 HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC] 2 HALOBETASOL PROPIONATE ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 HALOBETASOL ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 STEARETH-21 INACTIVE INGREDIENT 53J3F32P58 HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-129 HALOBETASOL PROPIONATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 6 Current NDC, Legacy NDC, 4 package rows 20240111_df26430c-8182-4d03-a254-06d913de4c95.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-129-32 45802012932 1 TUBE in 1 CARTON (45802-129-32) / 50 g in 1 TUBE 1 tube 2008-08-04 0000-00-00 No No Current 45802-129-35 45802012935 1 TUBE in 1 CARTON (45802-129-35) / 15 g in 1 TUBE 1 tube 2008-08-04 0000-00-00 No No Current