FDA.reportPublic FDA data

CALCITRIOL

Product NDC
23155-662
11-digit product format
231550662
Labeler code
23155
Product ID
23155-662_bbb5e828-e3b4-4ffd-8556-05651b1b77cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCITRIOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA091356
Marketing category
ANDA
Marketing start
2018-05-29
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, 308868

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-662-012020-03-11C16284748780-19d75b9d0-e629-f424-e053-dadaa90a57ceCalcitriol Capsules Rx only
23155-662-032020-03-11C16284748780-19d75b9d0-e629-f424-e053-dadaa90a57ceCalcitriol Capsules Rx only
23155-662-012020-01-31C16284748780-19d75b9d0-e629-f424-e053-dadaa90a57ceCalcitriol Capsules Rx only
23155-662-032020-01-31C16284748780-19d75b9d0-e629-f424-e053-dadaa90a57ceCalcitriol Capsules Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-662-01CALCITRIOL100 in 1 BOTTLECAPSULE1007
23155-662-03CALCITRIOL30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-662-01EA - Each23155-66256f39763-ebd4-47e3-9c4a-903973fae1c612018-07-03
23155-662-03EA - Each23155-66278b2c270-471e-4d0b-83bc-3da8c9091e5c12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-662CALCITRIOL CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250311_2b48f57a-c023-485d-b846-cab3aaaad486.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN2b48f57a-c023-485d-b846-cab3aaaad4867
308868calcitriol 0.5 MCG Oral CapsulePSN2b48f57a-c023-485d-b846-cab3aaaad4867
308867calcitriol 0.00025 MG Oral CapsuleSCD2b48f57a-c023-485d-b846-cab3aaaad4867
308868calcitriol 0.0005 MG Oral CapsuleSCD2b48f57a-c023-485d-b846-cab3aaaad4867
308867calcitriol 0.25 MCG Oral CapsuleSY2b48f57a-c023-485d-b846-cab3aaaad4867
308868calcitriol 0.5 MCG Oral CapsuleSY2b48f57a-c023-485d-b846-cab3aaaad4867
308867calcitriol 0.25 MCG Oral CapsulePSN26ac6b4d-9576-4710-856b-aca114ea84cf1
308867calcitriol 0.00025 MG Oral CapsuleSCD26ac6b4d-9576-4710-856b-aca114ea84cf1
308867calcitriol 0.25 MCG Oral CapsuleSY26ac6b4d-9576-4710-856b-aca114ea84cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-662-0123155066201100 CAPSULE in 1 BOTTLE (23155-662-01) 100 capsule2018-05-290000-00-00NoNoCurrent
23155-662-032315506620330 CAPSULE in 1 BOTTLE (23155-662-03) 30 capsule2018-05-290000-00-00NoNoCurrent