FDA.reportPublic FDA data

Rocaltrol

Product NDC
30698-144
11-digit product format
306980144
Labeler code
30698
Product ID
30698-144_73cbee56-369c-478d-84e8-df500e69dc82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitriol
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA018044
Marketing category
NDA
Marketing start
2009-08-20
Marketing end
0000-00-00
Substance
CALCITRIOL
Active strength
1 ug/1
Pharmacologic classes
Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
30698-144-012025-01-31C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL
30698-144-012023-12-14C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL
30698-144-012023-01-30C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-144-01Rocaltrol100 in 1 BOTTLECAPSULE, GELATIN COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-144-01EA - Each30698-144968f39c4-e0ba-47ab-b0be-7e71be4ea0c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
CALCITRIOLACTIVE MOIETYFXC9231JVHROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
PALM OILINACTIVE INGREDIENT5QUO05548ZROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-144ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]6Legacy NDC, 1 package rows20231215_d1013494-bf62-4e68-9f0c-e6571137f20f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.5 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 1 MCG in 1 mL Oral SolutionPSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.25 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.5 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 1 MCG in 1 mL Oral SolutionPSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209006calcitriol 0.00025 MG Oral Capsule [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
209007calcitriol 0.0005 MG Oral Capsule [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
261283calcitriol 0.001 MG/ML Oral Solution [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
308867calcitriol 0.00025 MG Oral CapsuleSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.0005 MG Oral CapsuleSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 0.001 MG/ML Oral SolutionSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
308867calcitriol 0.25 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.5 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 1 MCG per 1 ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.00025 MG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.0005 MG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 0.001 MG/ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.25 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.5 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 1 MCG per 1 ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30698-144-0130698014401100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-144-01) 2009-08-200000-00-00NoNoCurrent