FDA.reportPublic FDA data

Calcitriol

Product NDC
17478-831
11-digit product format
174780831
Labeler code
17478
Product ID
17478-831_c530bfdb-720f-4a88-88dd-af2bf93798b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
ANDA078066
Marketing category
ANDA
Marketing start
2013-03-22
Marketing end
0000-00-00
Substance
CALCITRIOL
Active strength
1 ug/mL
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-831-012024-01-30C16284748780-11030e365-33a7-111a-e063-dadaa90a10e2CALCITRIOL INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-831-01Calcitriol1 mL in 1 AMPULEINJECTION16
17478-831-01Calcitriol10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-831-01ML - Milliliter17478-831b0369ef5-c8a2-4e2f-a6a5-43e27d8d265d12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CalcitriolACTIVE INGREDIENTFXC9231JVHCALCITRIOL INJECTION [AKORN, INC.]2
CalcitriolACTIVE MOIETYFXC9231JVHCALCITRIOL INJECTION [AKORN, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCALCITRIOL INJECTION [AKORN, INC.]2
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCALCITRIOL INJECTION [AKORN, INC.]2
Sodium AscorbateINACTIVE INGREDIENTS033EH8359CALCITRIOL INJECTION [AKORN, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XCALCITRIOL INJECTION [AKORN, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CALCITRIOL INJECTION [AKORN, INC.]2
Sodium Phosphate, Monobasic, MonohydrateINACTIVE INGREDIENT593YOG76RNCALCITRIOL INJECTION [AKORN, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RCALCITRIOL INJECTION [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-831CALCITRIOL INJECTION [AKORN]6Legacy NDC, 2 package rows20220913_f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308869calcitriol 1 MCG in 1 ML InjectionPSNf3b180dd-6c0b-4c15-85d3-bbbb5176d1d16
3088691 ML calcitriol 0.001 MG/ML InjectionSCDf3b180dd-6c0b-4c15-85d3-bbbb5176d1d16
308869calcitriol 1 MCG per 1 ML InjectionSYf3b180dd-6c0b-4c15-85d3-bbbb5176d1d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-831-011747808310110 AMPULE in 1 CARTON (17478-831-01) > 1 mL in 1 AMPULE10 ampule2013-03-220000-00-00NoNoCurrent