taclonex

Generic: calcipotriene and betamethasone dipropionate

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

Drug Facts

Product Profile

Brand Name taclonex
Generic Name calcipotriene and betamethasone dipropionate
Labeler leo pharma inc.
Dosage Form SUSPENSION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
LEO Pharma Inc.

Identifiers & Regulatory

Product NDC 50222-501
Product ID 50222-501_5d56e57e-6b91-4916-96d8-6dca1af7487d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022185
Listing Expiration 2026-12-31
Marketing Start 2008-06-01

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 50222501
Hyphenated Format 50222-501

Supplemental Identifiers

RxCUI
833461 833463
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 taclonex (source: ndc)
Generic Name calcipotriene and betamethasone dipropionate (source: ndc)
Application Number NDA022185 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
  • 50 ug/g
source: ndc
Packaging
  • 40 CARTON in 1 CASE (50222-501-06) / 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE
  • 10 PACKAGE in 1 BOX (50222-501-66) / 2 BOTTLE in 1 PACKAGE / 60 g in 1 BOTTLE
source: ndc

Packages (2)

50222-501-06 40 CARTON in 1 CASE (50222-501-06) / 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE 50222-501-66 10 PACKAGE in 1 BOX (50222-501-66) / 2 BOTTLE in 1 PACKAGE / 60 g in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

TACLONEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "5d56e57e-6b91-4916-96d8-6dca1af7487d", "openfda": {"unii": ["826Y60901U", "S7499TYY6G"], "rxcui": ["833461", "833463"], "spl_set_id": ["757c914f-dd8d-43cc-a973-212d591af4af"], "manufacturer_name": ["LEO Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CARTON in 1 CASE (50222-501-06)  / 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE", "package_ndc": "50222-501-06", "marketing_start_date": "20080601"}, {"sample": false, "description": "10 PACKAGE in 1 BOX (50222-501-66)  / 2 BOTTLE in 1 PACKAGE / 60 g in 1 BOTTLE", "package_ndc": "50222-501-66", "marketing_start_date": "20080601"}], "brand_name": "TACLONEX", "product_id": "50222-501_5d56e57e-6b91-4916-96d8-6dca1af7487d", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Vitamin D Analog [EPC]", "Vitamin D [CS]"], "product_ndc": "50222-501", "generic_name": "calcipotriene and betamethasone dipropionate", "labeler_name": "LEO Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TACLONEX", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}, {"name": "CALCIPOTRIENE HYDRATE", "strength": "50 ug/g"}], "application_number": "NDA022185", "marketing_category": "NDA", "marketing_start_date": "20080601", "listing_expiration_date": "20261231"}