Home NDC 10631-122-51 Ultravate
Product NDC 10631-122
Requested package NDC 10631-122-51
11-digit product format 106310122
Labeler code 10631
Product ID 10631-122_8afe3d44-b60c-4ba2-ab6c-8da871fc62b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name halobetasol propionate
Dosage form LOTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA208183
Marketing category NDA
Marketing start 2016-03-01
Marketing end 0000-00-00
Substance HALOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 8 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…
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 N208183-001 ULTRAVATE HALOBETASOL PROPIONATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03
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 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD 2015-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208183-001 ULTRAVATE 0.05% LOTION / TOPICAL RLD, RS 2015-11-06 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208183-001 8962028 2033-06-19 U-1775 Drug product 2015-12-03 cb3db0bc1861…
Observed Orange Book exclusivity history# 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 10631-122-51 10631012251 2 BOTTLE in 1 CARTON (10631-122-51) > 59 g in 1 BOTTLE (10631-122-04) 2 bottle 2018-03-19 0000-00-00 No No Current