FDA.reportPublic FDA data

CALCITRIOL

Product NDC
63304-239
11-digit product format
633040239
Labeler code
63304
Product ID
63304-239_ccc0e02b-bd1e-45f2-9256-6933ac193518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCITRIOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA018044
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-08-26
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, 313932

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-239-01CALCITRIOL100 in 1 BOTTLECAPSULE1004
63304-239-30CALCITRIOL30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-239-01EA - Each63304-239e7c394b1-e51a-42b4-a9f1-f8a324c81c1312012-07-24
63304-239-30EA - Each63304-239433d5c69-7d9a-4d35-8dea-6df0279a53d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
PALM OILINACTIVE INGREDIENT5QUO05548ZCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-239CALCITRIOL CAPSULE CALCITRIOL SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20180823_66a69351-5b09-4368-a9fa-acf81b5ad882.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.5 MCG Oral CapsulePSN66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 1 MCG in 1 mL Oral SolutionPSN66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.00025 MG Oral CapsuleSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.0005 MG Oral CapsuleSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 0.001 MG/ML Oral SolutionSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.25 MCG Oral CapsuleSY66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.5 MCG Oral CapsuleSY66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 1 MCG per 1 ML Oral SolutionSY66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.25 MCG Oral CapsulePSN2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.00025 MG Oral CapsuleSCD2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.25 MCG Oral CapsuleSY2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.25 MCG Oral CapsulePSNc64778c6-3be6-44f5-8387-ebcd82e3eae51
308867calcitriol 0.00025 MG Oral CapsuleSCDc64778c6-3be6-44f5-8387-ebcd82e3eae51
308867calcitriol 0.25 MCG Oral CapsuleSYc64778c6-3be6-44f5-8387-ebcd82e3eae51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-239-0163304023901100 CAPSULE in 1 BOTTLE (63304-239-01) 100 capsule2009-08-260000-00-00NoNoCurrent
63304-239-306330402393030 CAPSULE in 1 BOTTLE (63304-239-30) 30 capsule2009-08-260000-00-00NoNoCurrent