enstilar

Generic: calcipotriene and betamethasone dipropionate

Labeler: leo pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name enstilar
Generic Name calcipotriene and betamethasone dipropionate
Labeler leo pharma inc.
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

betamethasone dipropionate .5 mg/g, calcipotriene monohydrate 50 ug/g

Manufacturer
LEO Pharma Inc.

Identifiers & Regulatory

Product NDC 50222-302
Product ID 50222-302_0b771976-2050-4eef-bc39-3c853c7c0ac2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207589
Listing Expiration 2026-12-31
Marketing Start 2015-10-16

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc] vitamin d analog [epc] vitamin d [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50222302
Hyphenated Format 50222-302

Supplemental Identifiers

RxCUI
1716094 1716099
UNII
826Y60901U S7499TYY6G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enstilar (source: ndc)
Generic Name calcipotriene and betamethasone dipropionate (source: ndc)
Application Number NDA207589 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
  • 50 ug/g
source: ndc
Packaging
  • 1 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN
  • 2 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN
  • 1 CAN in 1 CARTON (50222-302-91) / 60 g in 1 CAN
source: ndc

Packages (3)

50222-302-60 1 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN 50222-302-66 2 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN 50222-302-91 1 CAN in 1 CARTON (50222-302-91) / 60 g in 1 CAN

Ingredients (2)

betamethasone dipropionate (.5 mg/g) calcipotriene monohydrate (50 ug/g)

Linked Drug Pages (1)

ENSTILAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0b771976-2050-4eef-bc39-3c853c7c0ac2", "openfda": {"unii": ["826Y60901U", "S7499TYY6G"], "rxcui": ["1716094", "1716099"], "spl_set_id": ["d1193df2-d53f-4342-bd9d-d9cba7c89709"], "manufacturer_name": ["LEO Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CARTON (50222-302-60)  / 60 g in 1 CAN", "package_ndc": "50222-302-60", "marketing_start_date": "20151016"}, {"sample": false, "description": "2 CAN in 1 CARTON (50222-302-66)  / 60 g in 1 CAN", "package_ndc": "50222-302-66", "marketing_start_date": "20151016"}, {"sample": true, "description": "1 CAN in 1 CARTON (50222-302-91)  / 60 g in 1 CAN", "package_ndc": "50222-302-91", "marketing_start_date": "20151016"}], "brand_name": "ENSTILAR", "product_id": "50222-302_0b771976-2050-4eef-bc39-3c853c7c0ac2", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Vitamin D Analog [EPC]", "Vitamin D [CS]"], "product_ndc": "50222-302", "generic_name": "calcipotriene and betamethasone dipropionate", "labeler_name": "LEO Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENSTILAR", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CALCIPOTRIENE MONOHYDRATE", "strength": "50 ug/g"}], "application_number": "NDA207589", "marketing_category": "NDA", "marketing_start_date": "20151016", "listing_expiration_date": "20261231"}