Home NDC 0713-0640 Halobetasol Propionate
Product NDC 0713-0640
11-digit product format 007130640
Labeler code 0713
Product ID 0713-0640_0acd2432-98e5-018e-e063-6294a90ad373
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA078162
Marketing category ANDA
Marketing start 2007-07-16
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 42 .
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 A078162-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078162-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078162-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB RS 2007-04-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 0713-0640-15 Halobetasol Propionate 15 g in 1 TUBE CREAM 15 8 0713-0640-86 Halobetasol Propionate 50 g in 1 TUBE CREAM 50 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Halobetasol Propionate ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Halobetasol ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Diazolidinyl Urea INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Methylisothiazolinone INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Halobetasol Propionate ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Halobetasol ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Methylisothiazolinone INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Water INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0640 HALOBETASOL PROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231123_1f57aaae-8d5f-bfdf-08d6-495b84221311.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.
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 0713-0640-15 00713064015 15 g in 1 TUBE (0713-0640-15) 15 g 2007-07-16 0000-00-00 No No Current 0713-0640-86 00713064086 50 g in 1 TUBE (0713-0640-86) 50 g 2007-07-16 0000-00-00 No No Current