FDA.reportPublic FDA data

SORILUX

Product NDC
51862-376
11-digit product format
518620376
Labeler code
51862
Product ID
51862-376_cf0e1842-298b-47e7-9d51-f0789ae086ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mayne Pharma
Application
NDA022563
Marketing category
NDA
Marketing start
2017-04-11
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

Additional Listing Data#

Finished product
Yes
Brand name base
SORILUX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii143NQ3779B
Rxcui1020035, 1020039

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-376-12SORILUX1 in 1 CARTONAEROSOL, FOAM17
51862-376-12SORILUX120 g in 1 CANAEROSOL, FOAM1207
51862-376-60SORILUX1 in 1 CARTONAEROSOL, FOAM17
51862-376-60SORILUX60 g in 1 CANAEROSOL, FOAM607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-376SORILUX (CALCIPOTRIENE) AEROSOL, FOAM [MAYNE PHARMA]7Current NDC, Legacy NDC, 4 package rows20240511_51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020035calcipotriene 0.005 % Topical FoamPSN51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020039Sorilux 0.005 % Topical FoamPSN51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020039calcipotriene 0.05 MG/ML Topical Foam [Sorilux]SBD51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020035calcipotriene 0.05 MG/ML Topical FoamSCD51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020035calcipotriene 0.005 % Topical FoamSY51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020039Sorilux 0.005 % Topical FoamSY51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7
1020039Sorilux 0.05 MG/ML Topical FoamSY51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-376-12518620376121 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN1 can2017-04-110000-00-00NoNoCurrent
51862-376-60518620376601 CAN in 1 CARTON (51862-376-60) > 60 g in 1 CAN1 can2017-04-112023-06-30NoNoCurrent