FDA.reportPublic FDA data

Calcitriol

Product NDC
72789-058
11-digit product format
727890058
Labeler code
72789
Product ID
72789-058_2c25214d-d149-70d8-e063-6394a90a7b08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-058-01Calcitriol100 in 1 BOTTLE, PLASTICCAPSULE10020
72789-058-30Calcitriol30 in 1 BOTTLE, PLASTICCAPSULE3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-058CALCITRIOL CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20250121_e1fcb1c7-11a9-4a23-a64a-2c8ce9698321.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSNe1fcb1c7-11a9-4a23-a64a-2c8ce969832120
308867calcitriol 0.00025 MG Oral CapsuleSCDe1fcb1c7-11a9-4a23-a64a-2c8ce969832120
308867calcitriol 0.25 MCG Oral CapsuleSYe1fcb1c7-11a9-4a23-a64a-2c8ce969832120
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
72789-058-0172789005801100 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-01) 100 capsule2020-02-260000-00-00NoNoCurrent
72789-058-307278900583030 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-30) 30 capsule2023-07-14NoNoCurrent