Calcitriol

Product NDC
64980-447
11-digit product format
649800447
Labeler code
64980
Product ID
64980-447_9f3e830b-274e-43f4-b056-b607fec13df8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA209798
Marketing category
ANDA
Marketing start
2017-03-21
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
64980-447-15Calcitriol1 in 1 CARTONSOLUTION13
64980-447-15Calcitriol15 mL in 1 BOTTLE, GLASSSOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-447-15ML - Milliliter64980-447de638e0d-cc6e-45bf-961f-dbbb84b19d5712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-447CALCITRIOL SOLUTION [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 2 package rows20250419_1bd717a4-5fdf-4697-a6b2-9df55c6517bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313932calcitriol 1 MCG in 1 mL Oral SolutionPSN1bd717a4-5fdf-4697-a6b2-9df55c6517bb3
313932calcitriol 0.001 MG/ML Oral SolutionSCD1bd717a4-5fdf-4697-a6b2-9df55c6517bb3
313932calcitriol 1 MCG per 1 ML Oral SolutionSY1bd717a4-5fdf-4697-a6b2-9df55c6517bb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-447-15649800447151 BOTTLE, GLASS in 1 CARTON (64980-447-15) / 15 mL in 1 BOTTLE, GLASS2019-01-040000-00-00NoNoCurrent