TACLONEX

Product NDC
50222-501
11-digit product format
502220501
Labeler code
50222
Product ID
50222-501_5d56e57e-6b91-4916-96d8-6dca1af7487d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene and betamethasone dipropionate
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
LEO Pharma Inc.
Application
NDA022185
Marketing category
NDA
Marketing start
2008-06-01
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE
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
TACLONEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g
CALCIPOTRIENE HYDRATE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, S7499TYY6G
Rxcui833461, 833463

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50222-501-06TACLONEX1 in 1 CARTONSUSPENSION125
50222-501-06TACLONEX40 in 1 CASESUSPENSION4025
50222-501-51TACLONEX1 in 1 CARTONSUSPENSION125
50222-501-51TACLONEX40 in 1 CASESUSPENSION4025
50222-501-66TACLONEX2 in 1 PACKAGESUSPENSION225
50222-501-66TACLONEX10 in 1 BOXSUSPENSION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-501-06GM - Gram50222-501e8781476-328d-4898-82c6-b53864abfb8712012-07-24
50222-501-66GM - Gram50222-50197ca081c-0aea-4e6e-8d56-a480ae25d1ed12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
CALCIPOTRIENE HYDRATEACTIVE INGREDIENTS7499TYY6GTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
BETAMETHASONEACTIVE MOIETY9842X06Q6MTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
CALCIPOTRIENEACTIVE MOIETY143NQ3779BTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
PPG-11 STEARYL ETHERINACTIVE INGREDIENTS4G2J0Y0LGTACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]15
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CALCIPOTRIENEACTIVE INGREDIENT143NQ3779BTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CALCIPOTRIENEACTIVE MOIETY143NQ3779BTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50222-501TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]25Current NDC, Legacy NDC, 6 package rows20210703_757c914f-dd8d-43cc-a973-212d591af4af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833461calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical SuspensionPSN757c914f-dd8d-43cc-a973-212d591af4af25
833463Taclonex Scalp (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical SuspensionPSN757c914f-dd8d-43cc-a973-212d591af4af25
833463betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion [Taclonex]SBD757c914f-dd8d-43cc-a973-212d591af4af25
833461betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical LotionSCD757c914f-dd8d-43cc-a973-212d591af4af25
833461betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical SuspensionSY757c914f-dd8d-43cc-a973-212d591af4af25
833463Taclonex Scalp (calcipotriene 0.005 % / betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) ) Topical SuspensionSY757c914f-dd8d-43cc-a973-212d591af4af25
833461calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical SuspensionPSNd61c7acb-a64f-46ee-b125-0c80d3b355851
833463Taclonex Scalp (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical SuspensionPSNd61c7acb-a64f-46ee-b125-0c80d3b355851
833463betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion [Taclonex]SBDd61c7acb-a64f-46ee-b125-0c80d3b355851
833461betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical LotionSCDd61c7acb-a64f-46ee-b125-0c80d3b355851
833461betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical SuspensionSYd61c7acb-a64f-46ee-b125-0c80d3b355851
833463Taclonex Scalp (calcipotriene 0.005 % / betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) ) Topical SuspensionSYd61c7acb-a64f-46ee-b125-0c80d3b355851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50222-501-065022205010640 CARTON in 1 CASE (50222-501-06) / 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE40 carton2008-06-010000-00-00NoNoCurrent
50222-501-515022205015140 CARTON in 1 CASE (50222-501-51) > 1 BOTTLE in 1 CARTON > 4 g in 1 BOTTLE40 carton2008-06-010000-00-00NoNoCurrent
50222-501-665022205016610 PACKAGE in 1 BOX (50222-501-66) / 2 BOTTLE in 1 PACKAGE / 60 g in 1 BOTTLE10 package2008-06-010000-00-00NoNoCurrent