Home NDC 0713-0339 Halobetasol Propionate
Product NDC 0713-0339
11-digit product format 007130339
Labeler code 0713
Product ID 0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077109
Marketing category ANDA
Marketing start 2005-06-14
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 A077109-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077109-001 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 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077109-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2005-06-14 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 977978 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 0713-0339-15 Halobetasol Propionate 1 in 1 CARTON OINTMENT 1 6 0713-0339-15 Halobetasol Propionate 15 g in 1 TUBE OINTMENT 15 6 0713-0339-86 Halobetasol Propionate 50 g in 1 TUBE OINTMENT 50 6 0713-0339-86 Halobetasol Propionate 1 in 1 CARTON OINTMENT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0339 HALOBETASOL PROPIONATE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20240418_f12ff257-dd77-4f9c-97c4-339784772d9f.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 0713-0339-15 00713033915 1 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBE 1 tube 2018-02-21 0000-00-00 No No Current 0713-0339-86 00713033986 1 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBE 1 tube 2018-02-21 0000-00-00 No No Current