Home NDC 0713-0758-86 Halobetasol Propionate
Product NDC 0713-0758
Requested package NDC 0713-0758-86
11-digit product format 007130758
Labeler code 0713
Product ID 0713-0758_dde31435-a635-4f8a-e053-2a95a90a6fd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077109
Marketing category ANDA
Marketing start 2019-05-21
Marketing end 2023-07-31
Substance HALOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0758-86 00713075886 1 TUBE in 1 CARTON (0713-0758-86) > 50 g in 1 TUBE 1 tube 2019-05-21 2023-07-31 No No Current