FDA.reportPublic FDA data

calcipotriene

Product NDC
68462-501
11-digit product format
684620501
Labeler code
68462
Product ID
68462-501_d0707037-c9cd-4c52-a1f5-4c8f72f62010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc.,USA
Application
ANDA205772
Marketing category
ANDA
Marketing start
2015-06-10
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
Rxcui313921

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-501-65Trionex1 in 1 CARTONCREAM50 ug in 1g10
68462-501-65Trionex60 g in 1 TUBECREAM60 g50 ug in 1g10
68462-501-65calcipotriene60 g in 1 TUBECREAM607
68462-501-65calcipotriene1 in 1 CARTONCREAM17
68462-501-66calcipotriene1 in 1 CARTONCREAM17
68462-501-66calcipotriene120 g in 1 TUBECREAM1207
68462-501-65Calyxra1 in 1 CARTONCREAM50 ug in 1g2
68462-501-65Calyxra60 g in 1 TUBECREAM60 g50 ug in 1g2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-501-65GM - Gram68462-50151b7bff7-8b9b-427f-bc99-ca5daf44ea1712015-07-20
68462-501-66GM - Gram68462-50121543911-95e9-47b6-a1a0-83a58c44ca5412015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIPOTRIENEACTIVE INGREDIENT143NQ3779BCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
CALCIPOTRIENEACTIVE MOIETY143NQ3779BCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1
WATERINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-501TRIONEX (CALCIPOTRIENE CREAM, 0.005% AND TRANSPARENT DRESSING) KIT [V2 PHARMA, LLC]10Current NDC, Legacy NDC20230209_45ac2edf-7ed1-4862-888a-f9dd349f1930.zip
68462-501CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA]6Current NDC, Legacy NDC, 4 package rows20230427_7ec750f6-26ea-46bc-aa7b-174fd25253a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSN45ac2edf-7ed1-4862-888a-f9dd349f193010
313921calcipotriene 0.05 MG/ML Topical CreamSCD45ac2edf-7ed1-4862-888a-f9dd349f193010
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY45ac2edf-7ed1-4862-888a-f9dd349f193010
313921calcipotriene 0.005 % Topical CreamSY45ac2edf-7ed1-4862-888a-f9dd349f193010
313921calcipotriene 0.005 % Topical CreamPSN7ec750f6-26ea-46bc-aa7b-174fd25253a27
313921calcipotriene 0.05 MG/ML Topical CreamSCD7ec750f6-26ea-46bc-aa7b-174fd25253a27
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY7ec750f6-26ea-46bc-aa7b-174fd25253a27
313921calcipotriene 0.005 % Topical CreamSY7ec750f6-26ea-46bc-aa7b-174fd25253a27
313921calcipotriene 0.005 % Topical CreamPSNb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene 0.05 MG/ML Topical CreamSCDb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene 0.005 % Topical CreamSYb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene 0.005 % Topical CreamPSNaf2620a4-11b9-43a3-9164-d732a43769431
313921calcipotriene 0.05 MG/ML Topical CreamSCDaf2620a4-11b9-43a3-9164-d732a43769431
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYaf2620a4-11b9-43a3-9164-d732a43769431
313921calcipotriene 0.005 % Topical CreamSYaf2620a4-11b9-43a3-9164-d732a43769431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-501-65684620501651 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBE1 tube2015-06-100000-00-00NoNoCurrent
68462-501-66684620501661 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE1 tube2015-06-100000-00-00NoNoCurrent