Calcitriol

Product NDC
71610-468
11-digit product format
716100468
Labeler code
71610
Product ID
71610-468_e4a50edb-a1aa-436f-9379-63010ae70dae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091174
Marketing category
ANDA
Marketing start
2013-05-24
Substance
CALCITRIOL
Active strength
.25 ug/1
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcitriol
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
98f556da-44be-c658-496e-47884da4e67bProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-468-09Calcitriol9000 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED90002
71610-468-30Calcitriol30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-468CALCITRIOL CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20230615_3c40c40c-1627-4bcd-ba35-bee9b952d985.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN3c40c40c-1627-4bcd-ba35-bee9b952d9852
308867calcitriol 0.00025 MG Oral CapsuleSCD3c40c40c-1627-4bcd-ba35-bee9b952d9852
308867calcitriol 0.25 MCG Oral CapsuleSY3c40c40c-1627-4bcd-ba35-bee9b952d9852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-468-09716100468099000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09) 2020-09-210000-00-00NoNoCurrent
71610-468-307161004683030 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30) 2023-06-12NoNoCurrent