calcitriol

Product NDC
45802-608
11-digit product format
458020608
Labeler code
45802
Product ID
45802-608_d1600f2d-9c61-486e-9ef0-54160ef6adc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitriol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA022087
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-03-08
Substance
CALCITRIOL
Active strength
3 ug/g
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
CALCITRIOL3 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFXC9231JVH
Rxcui388517

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
45802-608-01calcitriol100 g in 1 TUBEOINTMENT1007
45802-608-01calcitriol1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-608-01GM - Gram45802-6085a018c3d-5a3d-4999-b5be-8b24905c218a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01CALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-608CALCITRIOL OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20230306_7fa4ab07-3d8e-4300-91f3-b1e17cba8691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388517calcitriol 0.0003 % Topical OintmentPSN7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 0.000003 MG/MG Topical OintmentSCD7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 0.0003 % Topical OintmentSY7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 3 MCG/GM Topical OintmentSY7fa4ab07-3d8e-4300-91f3-b1e17cba86917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-608-01458020608011 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE1 tube2012-03-080000-00-00NoNoCurrent