Home NDC 21922-108-04 Halobetasol Propionate
Product NDC 21922-108
Requested package NDC 21922-108-04
11-digit product format 219220108
Labeler code 21922
Product ID 21922-108_b933ad2a-8b48-4127-a66b-aa70024a02c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA209978
Marketing category ANDA
Marketing start 2026-07-01
Substance HALOBETASOL PROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A209978-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209978-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2018-03-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209978-001 HALOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-03-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Halobetasol Propionate
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-108-04 21922010804 1 TUBE in 1 CARTON (21922-108-04) / 15 g in 1 TUBE 1 tube 2026-07-01 No No Current