CALCIPOTRIENE

Product NDC
73308-357
11-digit product format
733080357
Labeler code
73308
Product ID
73308-357_daa23f12-65d4-4b3e-ae99-1f940674cb2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Ayurax
Application
NDA022563
Marketing category
NDA
Marketing start
2020-01-08
Marketing end
0000-00-00
Substance
CALCIPOTRIENE
Active strength
50 ug/g
Pharmacologic classes
Vitamin D [CS],Vitamin D Analog [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73308-357DDiscontinued by firm2026-08-03
excluded packagepackage73308-35773308-357-60DDiscontinued by firm2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73308-357-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73308-357-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73308-357-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73308-357-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73308-357-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73308-357-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73308-357-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73308-357-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73308-357-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73308-357-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73308-357-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73308-357-60557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022563-001SORILUXCALCIPOTRIENE0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022563-00186291282026-05-26U-1280Drug product2014-04-17
N022563-00186291282026-05-26U-1767Drug product2014-04-17
N022563-00186291282026-05-26U-2662Drug product2014-04-17
N022563-00182635802028-05-07U-1280Drug product2012-09-21
N022563-00182635802028-05-07U-2662Drug product2012-09-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022563-001SORILUX0.005%AEROSOL, FOAM / TOPICALRLD, RS2010-10-06cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 5 · 199 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022563-00186291282026-05-26U-1280Drug product2014-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022563-00186291282026-05-26U-1767Drug product2014-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022563-00186291282026-05-26U-2662Drug product2014-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022563-00182635802028-05-07U-1280Drug product2012-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022563-00182635802028-05-07U-2662Drug product2012-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-00186291282026-05-26U-1280Drug product2014-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-00186291282026-05-26U-1767Drug product2014-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-00186291282026-05-26U-2662Drug product2014-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-00182635802028-05-07U-1280Drug product2012-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022563-00182635802028-05-07U-2662Drug product2012-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022563-00186291282026-05-26U-1280Drug product2014-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022563-00186291282026-05-26U-1767Drug product2014-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022563-00186291282026-05-26U-2662Drug product2014-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022563-00182635802028-05-07U-1280Drug product2012-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022563-00182635802028-05-07U-2662Drug product2012-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-00186291282026-05-26U-1280Drug product2014-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-00186291282026-05-26U-1767Drug product2014-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-00186291282026-05-26U-2662Drug product2014-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-00182635802028-05-07U-1280Drug product2012-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022563-00182635802028-05-07U-2662Drug product2012-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-00186291282026-05-26U-1280Drug product2014-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-00186291282026-05-26U-1767Drug product2014-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-00186291282026-05-26U-2662Drug product2014-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-00182635802028-05-07U-1280Drug product2012-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022563-00182635802028-05-07U-2662Drug product2012-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-00186291282026-05-26U-1280Drug product2014-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-00186291282026-05-26U-1767Drug product2014-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-00186291282026-05-26U-2662Drug product2014-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-00182635802028-05-07U-1280Drug product2012-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022563-00182635802028-05-07U-2662Drug product2012-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-00186291282026-05-26U-1280Drug product2014-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-00186291282026-05-26U-1767Drug product2014-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-00186291282026-05-26U-2662Drug product2014-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-00182635802028-05-07U-1280Drug product2012-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022563-00182635802028-05-07U-2662Drug product2012-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-00186291282026-05-26U-1280Drug product2014-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-00186291282026-05-26U-1767Drug product2014-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-00186291282026-05-26U-2662Drug product2014-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-00182635802028-05-07U-1280Drug product2012-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022563-00182635802028-05-07U-2662Drug product2012-09-215bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022563-001NPP2022-05-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022563-001NPP2022-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022563-001NPP2022-05-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022563-001NPP2022-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022563-001NPP2022-05-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022563-001NPP2022-11-054b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022563-001NPP2022-05-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022563-001NPP2022-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022563-001NPP2022-05-06782e0a99824c…
2021-12-28 21:50 UTC2021-12N022563-001NPP2022-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022563-001NPP2022-05-0687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022563-001NPP2022-11-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N022563-001NPP2022-05-065aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022563-001NPP2022-11-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022563-001NPP2022-05-068869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022563-001NPP2022-11-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022563-001NPP2022-05-06c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022563-001NPP2022-11-05c0c555d07b60…
2023-01-26 05:58 UTC2023-01N022563-001NPP2022-05-063bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N022563-001NPP2022-11-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022563-001NPP2022-05-063a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022563-001NPP2022-11-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022563-001NPP2022-05-06f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N022563-001NPP2022-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022563-001NPP2022-05-06e64feba35796…
2022-09-29 23:25 UTC2022-09N022563-001NPP2022-11-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022563-001NPP2022-05-06cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022563-001NPP2022-11-05cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73308-357-60GM - Gram73308-35743144389-a66b-407e-ae62-d85495f74dec12020-02-13

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcipotrieneCALCIPOTRIENEMayne Pharma26756ac7-a80c-49db-97bb-351f76ad8a712024-05-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 022563
application number: NDA022563
SORILUXCALCIPOTRIENEMayne Pharma51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe2024-05-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 022563
application number: NDA022563