FDA.reportPublic FDA data

calcipotriene

Product NDC
66993-878
11-digit product format
669930878
Labeler code
66993
Product ID
66993-878_701245ab-fce0-4a80-90c7-9e3cfa79a9f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA020273
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-07-01
Substance
CALCIPOTRIENE
Active strength
50 ug/g
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
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii143NQ3779B
Rxcui198373

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-878-61calcipotriene60 g in 1 TUBEOINTMENT609
66993-878-61calcipotriene1 in 1 CARTONOINTMENT19
66993-878-78calcipotriene120 g in 1 TUBEOINTMENT1209
66993-878-78calcipotriene1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-878-61GM - Gram66993-87852419c27-1157-4352-990d-0843efe06fe312013-09-04
66993-878-78GM - Gram66993-8788abf4060-2cc7-4fcd-acf1-0ddb4203fd5a12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIPOTRIENEACTIVE INGREDIENT143NQ3779BCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
CALCIPOTRIENEACTIVE MOIETY143NQ3779BCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-878CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]9Current NDC, Legacy NDC, 4 package rows20200813_fe7cd92a-f066-4c4a-80c8-e3f929ad4181.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198373calcipotriene 0.005 % Topical OintmentPSNfe7cd92a-f066-4c4a-80c8-e3f929ad41819
198373calcipotriene 0.00005 MG/MG Topical OintmentSCDfe7cd92a-f066-4c4a-80c8-e3f929ad41819
198373calcipotriene 0.005 % Topical OintmentSYfe7cd92a-f066-4c4a-80c8-e3f929ad41819
198373calcipotriene 50 MCG/GM Topical OintmentSYfe7cd92a-f066-4c4a-80c8-e3f929ad41819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-878-61669930878611 TUBE in 1 CARTON (66993-878-61) / 60 g in 1 TUBE1 tube2013-07-010000-00-00NoNoCurrent
66993-878-78669930878781 TUBE in 1 CARTON (66993-878-78) / 120 g in 1 TUBE1 tube2013-07-010000-00-00NoNoCurrent