Home NDC 51862-512 calcipotriene
Product NDC 51862-512
11-digit product format 518620512
Labeler code 51862
Product ID 51862-512_8200e8ca-3486-4e51-8a3c-6efee8913d50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Mayne Pharma
Application NDA022563
Marketing category NDA
Marketing start 2021-02-15
Substance CALCIPOTRIENE
Active strength 50 ug/g
Pharmacologic classes Vitamin D Analog [EPC], Vitamin D [CS]
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 N022563-001 SORILUX CALCIPOTRIENE 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21
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 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 199 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 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base calcipotriene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIPOTRIENE 50 ug/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 143NQ3779B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020035 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 51862-512-60 calcipotriene 1 in 1 CARTON AEROSOL, FOAM 1 4 51862-512-60 calcipotriene 60 g in 1 CAN AEROSOL, FOAM 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-512 CALCIPOTRIENE AEROSOL, FOAM [MAYNE PHARMA] 4 Current NDC, Legacy NDC, 2 package rows 20240511_26756ac7-a80c-49db-97bb-351f76ad8a71.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 51862-512-60 51862051260 1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN 1 can 2021-02-15 0000-00-00 No No Current