Calcipotriene

Product NDC
0713-0318
11-digit product format
007130318
Labeler code
0713
Product ID
0713-0318_ed81406a-8c10-5c33-e053-2a95a90a941f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA078468
Marketing category
ANDA
Marketing start
2011-03-24
Substance
CALCIPOTRIENE
Active strength
.05 mg/mL
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
Calcipotriene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii143NQ3779B
Rxcui308865

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0318-53Calcipotriene1 in 1 CARTONSOLUTION110
0713-0318-53Calcipotriene60 mL in 1 BOTTLESOLUTION6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0318CALCIPOTRIENE SOLUTION [COSETTE PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20221116_21378c25-5622-8bf7-1a8c-b05940a846a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308865calcipotriene 0.005 % Topical SolutionPSN21378c25-5622-8bf7-1a8c-b05940a846a010
308865calcipotriene 0.05 MG/ML Topical SolutionSCD21378c25-5622-8bf7-1a8c-b05940a846a010
308865calcipotriene 0.005 % Topical SolutionSY21378c25-5622-8bf7-1a8c-b05940a846a010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0318-53007130318531 BOTTLE in 1 CARTON (0713-0318-53) / 60 mL in 1 BOTTLE1 bottle2011-03-240000-00-00NoNoCurrent