Calcitriol

Product NDC
55154-8186
11-digit product format
551548186
Labeler code
55154
Product ID
55154-8186_41375ecd-2ee0-48d1-807a-c4506d2de91f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol Capsules 0.25 mcg
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA091356
Marketing category
ANDA
Marketing start
2019-01-23
Substance
CALCITRIOL
Active strength
.25 ug/1
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcitriol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITRIOL.25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFXC9231JVH
Rxcui308867

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8186-0Calcitriol1 in 1 BLISTER PACKCAPSULE17
55154-8186-0Calcitriol10 in 1 BAGCAPSULE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8186CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20241109_32205cfc-7939-4105-a4b9-2ed327c5e0cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN32205cfc-7939-4105-a4b9-2ed327c5e0cc7
308867calcitriol 0.00025 MG Oral CapsuleSCD32205cfc-7939-4105-a4b9-2ed327c5e0cc7
308867calcitriol 0.25 MCG Oral CapsuleSY32205cfc-7939-4105-a4b9-2ed327c5e0cc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8186-05515481860010 BLISTER PACK in 1 BAG (55154-8186-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2019-01-230000-00-00NoNoCurrent