Home NDC 68308-769 Halobetasol propionate
Product NDC 68308-769
11-digit product format 683080769
Labeler code 68308
Product ID 68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol propionate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Mayne Pharma
Application ANDA215266
Marketing category ANDA
Marketing start 2023-11-27
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 A215266-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL RS 2023-08-11
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.
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 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB 2023-08-11 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215266-001 HALOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL RS 2023-08-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215266-001 PC 2024-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215266-001 PC 2024-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215266-001 PC 2024-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215266-001 PC 2024-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215266-001 PC 2024-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215266-001 PC 2024-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215266-001 PC 2024-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215266-001 PC 2024-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215266-001 PC 2024-06-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215266-001 PC 2024-06-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215266-001 PC 2024-06-24 1c564ffb4f44…
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 2047646 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 68308-769-50 Halobetasol propionate 1 in 1 CARTON AEROSOL, FOAM 1 3 68308-769-50 Halobetasol propionate 50 g in 1 CANISTER AEROSOL, FOAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-769 HALOBETASOL PROPIONATE AEROSOL, FOAM [MAYNE PHARMA] 2 Current NDC, 2 package rows 20231205_24c41e6d-a314-4984-b45f-e5aa1fffa9b6.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 Sample Exclude flag Status 68308-769-50 68308076950 1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER 1 canister 2023-12-01 No No Current