Calcitrene

Product NDC
51672-5278
11-digit product format
516725278
Labeler code
51672
Product ID
51672-5278_5d928da9-5181-4a23-a067-27b596d7136a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA090633
Marketing category
ANDA
Marketing start
2010-03-24
Substance
CALCIPOTRIENE
Active strength
.05 mg/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
Calcitrene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE.05 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii143NQ3779B
Rxcui198373, 1013636

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
51672-5278-3Calcitrene1 in 1 CARTONOINTMENT13
51672-5278-3Calcitrene60 g in 1 TUBEOINTMENT603
51672-5278-4Calcitrene120 g in 1 TUBEOINTMENT1203
51672-5278-4Calcitrene1 in 1 CARTONOINTMENT13
51672-5278-5Calcitrene5 g in 1 TUBEOINTMENT53
51672-5278-5Calcitrene10 in 1 CARTONOINTMENT103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5278CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 6 package rows20190208_94d4f46a-f254-4fe2-b4bd-7a533d6324fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198373calcipotriene 0.005 % Topical OintmentPSN94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
1013636Calcitrene 0.005 % Topical OintmentPSN94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
1013636calcipotriene 0.00005 MG/MG Topical Ointment [Calcitrene]SBD94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
198373calcipotriene 0.00005 MG/MG Topical OintmentSCD94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
198373calcipotriene 0.005 % Topical OintmentSY94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
198373calcipotriene 50 MCG/GM Topical OintmentSY94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
1013636Calcitrene 0.00005 MG/MG Topical OintmentSY94d4f46a-f254-4fe2-b4bd-7a533d6324fe3
1013636Calcitrene 0.005 % Topical OintmentSY94d4f46a-f254-4fe2-b4bd-7a533d6324fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5278-3516725278031 TUBE in 1 CARTON (51672-5278-3) / 60 g in 1 TUBE1 tube2010-03-240000-00-00NoNoCurrent
51672-5278-4516725278041 TUBE in 1 CARTON (51672-5278-4) / 120 g in 1 TUBE1 tube2010-03-240000-00-00NoNoCurrent
51672-5278-55167252780510 TUBE in 1 CARTON (51672-5278-5) / 5 g in 1 TUBE10 tube2010-03-240000-00-00NoNoCurrent