Calcitriol

Product NDC
62756-967
11-digit product format
627560967
Labeler code
62756
Product ID
62756-967_fb99b865-fb41-4c92-8db9-7953feed2394
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204556
Marketing category
ANDA
Marketing start
2020-05-01
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
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-967-18Calcitriol1000 in 1 BOTTLECAPSULE, LIQUID FILLED10004
62756-967-83Calcitriol30 in 1 BOTTLECAPSULE, LIQUID FILLED304
62756-967-88Calcitriol100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-967CALCITRIOL CAPSULE, LIQUID FILLED [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 3 package rows20220118_97cf7807-3b48-403b-bae2-2fe585946e0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN97cf7807-3b48-403b-bae2-2fe585946e0c4
308868calcitriol 0.5 MCG Oral CapsulePSN97cf7807-3b48-403b-bae2-2fe585946e0c4
308867calcitriol 0.00025 MG Oral CapsuleSCD97cf7807-3b48-403b-bae2-2fe585946e0c4
308868calcitriol 0.0005 MG Oral CapsuleSCD97cf7807-3b48-403b-bae2-2fe585946e0c4
308867calcitriol 0.25 MCG Oral CapsuleSY97cf7807-3b48-403b-bae2-2fe585946e0c4
308868calcitriol 0.5 MCG Oral CapsuleSY97cf7807-3b48-403b-bae2-2fe585946e0c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-967-18627560967181000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-18) 2020-05-010000-00-00NoNoCurrent
62756-967-836275609678330 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-83) 2020-05-010000-00-00NoNoCurrent
62756-967-8862756096788100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-88) 2020-05-010000-00-00NoNoCurrent