Calcipotriene

Product NDC
50383-732
11-digit product format
503830732
Labeler code
50383
Product ID
50383-732_2972f2c6-2e0f-4525-824e-458223d3ffef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Akorn
Application
ANDA077579
Marketing category
ANDA
Marketing start
2014-10-06
Marketing end
0000-00-00
Substance
CALCIPOTRIENE HYDRATE
Active strength
0 mg/mL
Pharmacologic classes
Vitamin D Analog [EPC], Vitamin D [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-732-022025-09-10C16284748780-11030e365-5956-111a-e063-dadaa90a10e253c9942a-e861-493f-95c2-53446bc5f06d
50383-732-022024-01-30C16284748780-11030e365-5956-111a-e063-dadaa90a10e253c9942a-e861-493f-95c2-53446bc5f06d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-732-02ML - Milliliter50383-7328cedde90-fd1c-4578-bec3-1779855a4c1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIPOTRIENE HYDRATEACTIVE INGREDIENTS7499TYY6GCALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
CALCIPOTRIENEACTIVE MOIETY143NQ3779BCALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE SOLUTION [HI-TECH PHARMACAL CO., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-732CALCIPOTRIENE SOLUTION [AKORN]9Legacy NDC20220920_53c9942a-e861-493f-95c2-53446bc5f06d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-732-02503830732021 BOTTLE in 1 CARTON (50383-732-02) > 60 mL in 1 BOTTLE1 bottle2014-10-060000-00-00NoNoCurrent