FDA.reportPublic FDA data

Calcipotriene

Product NDC
66993-877
11-digit product format
669930877
Labeler code
66993
Product ID
66993-877_3682f2c5-9bce-4b4a-a4d6-9af29f08ad63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
CREAM
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA020554
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-10-01
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
Rxcui313921

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-877-61Calcipotriene1 in 1 CARTONCREAM110
66993-877-61Calcipotriene60 g in 1 TUBECREAM6010
66993-877-78Calcipotriene120 g in 1 TUBECREAM12010
66993-877-78Calcipotriene1 in 1 CARTONCREAM110
66993-877-61NuDermRxPAK 601 in 1 CARTONCREAM50 ug in 1g2
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g2
66993-877-78NuDermRxPAK 1201 in 1 CARTONCREAM50 ug in 1g2
66993-877-78NuDermRxPAK 120120 g in 1 TUBECREAM120 g50 ug in 1g2
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g1
66993-877-78NuDermRxPAK 120120 g in 1 TUBECREAM120 g50 ug in 1g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-877-61GM - Gram66993-87701e3dce0-cd1c-4456-b145-3949f62c449112013-02-13
66993-877-78GM - Gram66993-87751370a47-3635-4678-82be-6599528acc5c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIPOTRIENEACTIVE INGREDIENT143NQ3779BCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CALCIPOTRIENEACTIVE MOIETY143NQ3779BCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
DICHLOROBENZYL ALCOHOLINACTIVE INGREDIENT1NKX3648J9CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-877CALCIPOTRIENE CREAM [PRASCO LABORATORIES]10Current NDC, Legacy NDC, 4 package rows20221213_377eafda-737c-4ba2-9ec5-61209b8814ed.zip
66993-877NUDERMRXPAK 120 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210506_a838204b-9564-9aa6-e053-2a95a90af02f.zip
66993-877NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210511_a837f13e-fafc-0535-e053-2995a90a5070.zip
66993-877NUDERMRXPAK 120 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC20190529_89f6689b-ef95-613b-e053-2a95a90ac161.zip
66993-877NUDERMRXPAK 60 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC20190525_89a98b7c-d36b-6016-e053-2a95a90aa31b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSN377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.05 MG/ML Topical CreamSCD377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.005 % Topical CreamSY377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.005 % Topical CreamPSNa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamPSNa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.05 MG/ML Topical CreamSCDa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.05 MG/ML Topical CreamSCDa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.005 % Topical CreamPSN89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamPSN89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.05 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.05 MG/ML Topical CreamSCD89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 50 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 50 MG/ML Topical CreamSCD89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene 0.005 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 5 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-877-61669930877611 TUBE in 1 CARTON (66993-877-61) / 60 g in 1 TUBE1 tube1996-10-010000-00-00NoNoCurrent
66993-877-78669930877781 TUBE in 1 CARTON (66993-877-78) / 120 g in 1 TUBE1 tube1996-10-010000-00-00NoNoCurrent