Calcitriol

Product NDC
39328-042
11-digit product format
393280042
Labeler code
39328
Product ID
39328-042_6590e5b0-9097-45ca-bc73-a3dededb6901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
SOLUTION
Route
ORAL
Labeler
Patrin Pharma, Inc
Application
ANDA203973
Marketing category
ANDA
Marketing start
2023-08-14
Substance
CALCITRIOL
Active strength
1 ug/mL
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
CALCITRIOL1 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFXC9231JVH
Rxcui313932

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
39328-042-15Calcitriol1 in 1 CARTONSOLUTION13
39328-042-15Calcitriol15 mL in 1 BOTTLE, GLASSSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-042CALCITRIOL SOLUTION [PATRIN PHARMA, INC]3Current NDC, 2 package rows20240123_c5c37779-0c26-438f-b1ca-61cf9915d233.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313932calcitriol 1 MCG in 1 mL Oral SolutionPSNc5c37779-0c26-438f-b1ca-61cf9915d2333
313932calcitriol 0.001 MG/ML Oral SolutionSCDc5c37779-0c26-438f-b1ca-61cf9915d2333
313932calcitriol 1 MCG per 1 ML Oral SolutionSYc5c37779-0c26-438f-b1ca-61cf9915d2333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
39328-042-15393280042151 BOTTLE, GLASS in 1 CARTON (39328-042-15) / 15 mL in 1 BOTTLE, GLASS2023-08-14NoNoCurrent