FDA.reportPublic FDA data

Calcitriol

Product NDC
0054-0007
11-digit product format
000540007
Labeler code
0054
Product ID
0054-0007_b5e53ff9-faab-4e0b-ae45-b3b2a4522557
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-0007-132022-04-26C16284748780-1d6a99b39-6201-a426-e053-dadaa90af4c2Calcitriol Capsules
0054-0007-252022-04-26C16284748780-1d6a99b39-6201-a426-e053-dadaa90af4c2Calcitriol Capsules
0054-0007-132022-01-28C16284748780-1d6a99b39-6201-a426-e053-dadaa90af4c2Calcitriol Capsules
0054-0007-252022-01-28C16284748780-1d6a99b39-6201-a426-e053-dadaa90af4c2Calcitriol Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0007-13Calcitriol30 in 1 BOTTLE, PLASTICCAPSULE3016
0054-0007-25Calcitriol100 in 1 BOTTLE, PLASTICCAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0007-13EA - Each0054-00079b7552c9-03ef-4cc9-8672-aa826c5b902f12012-07-24
0054-0007-25EA - Each0054-0007218664f5-3361-41a1-8c24-e759c84d0abb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.]8
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0007CALCITRIOL CAPSULE [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20240105_cdcaffc6-e14e-4607-b77b-fc78a8382f60.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 CapsulePSNcdcaffc6-e14e-4607-b77b-fc78a8382f6016
308867calcitriol 0.00025 MG Oral CapsuleSCDcdcaffc6-e14e-4607-b77b-fc78a8382f6016
308867calcitriol 0.25 MCG Oral CapsuleSYcdcaffc6-e14e-4607-b77b-fc78a8382f6016
308867calcitriol 0.25 MCG Oral CapsulePSN167a669f-7b7e-46ea-9331-567bf19d87873
308867calcitriol 0.00025 MG Oral CapsuleSCD167a669f-7b7e-46ea-9331-567bf19d87873
308867calcitriol 0.25 MCG Oral CapsuleSY167a669f-7b7e-46ea-9331-567bf19d87873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0007-130005400071330 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13) 30 capsule2006-03-270000-00-00NoNoCurrent
0054-0007-2500054000725100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25) 100 capsule2006-03-270000-00-00NoNoCurrent