Calcitriol

Product NDC
71610-521
11-digit product format
716100521
Labeler code
71610
Product ID
71610-521_73591ad3-4894-41a5-968a-1955b2a52105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076917
Marketing category
ANDA
Marketing start
2006-03-27
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
FXC9231JVHCALCITRIOL32222-06-3CALCITRIOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-521-09716100521099000 CAPSULE in 1 BOTTLE, PLASTIC (71610-521-09) 9000 capsule2021-02-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Calcitriol CapsulesAphena Pharma Solutions - Tennessee, LLC2021-03-14HUMAN PRESCRIPTION DRUG LABEL1