Calcitriol

Product NDC
71610-521
11-digit product format
716100521
Labeler code
71610
Product ID
71610-521_73591ad3-4894-41a5-968a-1955b2a52105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076917
Marketing category
ANDA
Marketing start
2006-03-27
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
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-521-09Calcitriol9000 in 1 BOTTLE, PLASTICCAPSULE90001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-521-09EA - Each71610-521ceffa4c8-2d31-42cf-9ced-332e19686f7712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-521CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20210320_adb1b2d5-33a7-4442-9074-cc1a89966528.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSNadb1b2d5-33a7-4442-9074-cc1a899665281
308867calcitriol 0.00025 MG Oral CapsuleSCDadb1b2d5-33a7-4442-9074-cc1a899665281
308867calcitriol 0.25 MCG Oral CapsuleSYadb1b2d5-33a7-4442-9074-cc1a899665281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-521-09716100521099000 CAPSULE in 1 BOTTLE, PLASTIC (71610-521-09) 9000 capsule2021-02-040000-00-00NoNoCurrent