FDA.reportPublic FDA data

ENSTILAR

Product NDC
50222-302
11-digit product format
502220302
Labeler code
50222
Product ID
50222-302_0b771976-2050-4eef-bc39-3c853c7c0ac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene and betamethasone dipropionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
LEO Pharma Inc.
Application
NDA207589
Marketing category
NDA
Marketing start
2015-10-16
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE
Active strength
.5; 50 mg/g; ug/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
ENSTILAR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g
CALCIPOTRIENE MONOHYDRATE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, S7499TYY6G
Rxcui1716094, 1716099

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50222-302-602020-08-25C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006
50222-302-662020-08-25C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006
50222-302-912020-08-25C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006
50222-302-602020-07-22C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006
50222-302-662020-07-22C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006
50222-302-912020-07-22C16284748780-1ab0e2407-33fd-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam. ENSTILAR ® (calcipotriene and betamethasone dipropionate) foam, for topical use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50222-302-60ENSTILAR60 g in 1 CANAEROSOL, FOAM6015
50222-302-60ENSTILAR1 in 1 CARTONAEROSOL, FOAM115
50222-302-66ENSTILAR60 g in 1 CANAEROSOL, FOAM6015
50222-302-66ENSTILAR2 in 1 CARTONAEROSOL, FOAM215
50222-302-91ENSTILAR60 g in 1 CANAEROSOL, FOAM6015
50222-302-91ENSTILAR1 in 1 CARTONAEROSOL, FOAM115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-302-60GM - Gram50222-30283b179bb-8016-4803-b826-c45710c6ea5112016-01-13
50222-302-66GM - Gram50222-3028b3fca47-704d-4d2c-b4ef-82a69162032612016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
CALCIPOTRIENE HYDRATEACTIVE INGREDIENTS7499TYY6GENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
CALCIPOTRIENEACTIVE MOIETY143NQ3779BENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
BUTANEINACTIVE INGREDIENT6LV4FOR43RENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
DIMETHYL ETHERINACTIVE INGREDIENTAM13FS69BXENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2
PPG-11 STEARYL ETHERINACTIVE INGREDIENTS4G2J0Y0LGENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50222-302ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.]15Current NDC, Legacy NDC, 6 package rows20220607_d1193df2-d53f-4342-bd9d-d9cba7c89709.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1716094calcipotriene 0.005 % / betamethasone propionate 0.064 % Topical FoamPSNd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716099Enstilar 0.005 % / 0.064 % Topical FoamPSNd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716099betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]SBDd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716094betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical FoamSCDd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716094calcipotriene 0.005 % / betamethasone propionate 0.064 % Topical FoamSYd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716099Enstilar (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical FoamSYd1193df2-d53f-4342-bd9d-d9cba7c8970915
1716099Enstilar 0.005 % / 0.064 % Topical FoamSYd1193df2-d53f-4342-bd9d-d9cba7c8970915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50222-302-60502220302601 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN1 can2015-10-160000-00-00NoNoCurrent
50222-302-66502220302662 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN2 can2015-10-160000-00-00NoNoCurrent
50222-302-91502220302911 CAN in 1 CARTON (50222-302-91) / 60 g in 1 CAN1 can2015-10-160000-00-00YesNoCurrent