NDC 43353-034

Calcitriol

Calcitriol

Calcitriol is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Calcitriol.

Product ID43353-034_6919ba25-ae85-4fdc-b8d7-48ce9b26e3d5
NDC43353-034
Product TypeHuman Prescription Drug
Proprietary NameCalcitriol
Generic NameCalcitriol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2006-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA076917
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameCALCITRIOL
Active Ingredient Strength0 ug/1
Pharm ClassesCholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-034-09

9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-09)
Marketing Start Date2013-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-034-81 [43353003481]

Calcitriol CAPSULE
Marketing CategoryANDA
Application NumberANDA076917
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-30

NDC 43353-034-09 [43353003409]

Calcitriol CAPSULE
Marketing CategoryANDA
Application NumberANDA076917
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-03

Drug Details

Active Ingredients

IngredientStrength
CALCITRIOL.25 ug/1

OpenFDA Data

SPL SET ID:167a669f-7b7e-46ea-9331-567bf19d8787
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308867

    • Pharmacological Class

    • Cholecalciferol [CS]
    • Vitamin D3 Analog [EPC]

    NDC Crossover Matching brand name "Calcitriol" or generic name "Calcitriol"

    NDCBrand NameGeneric Name
    0054-0007CalcitriolCalcitriol
    0054-3120CalcitriolCalcitriol
    0093-7352CalcitriolCalcitriol
    0093-7353CalcitriolCalcitriol
    0143-9728CalcitriolCalcitriol
    0179-0245CalcitriolCalcitriol
    17478-831CalcitriolCalcitriol
    17478-931CalcitriolCalcitriol
    17478-932CalcitriolCalcitriol
    17856-0723CalcitriolCalcitriol 0.25 mcg
    17856-3120CalcitriolCalcitriol
    23155-118CalcitriolCalcitriol
    23155-119CalcitriolCalcitriol
    23155-662CALCITRIOLCALCITRIOL
    23155-663CALCITRIOLCALCITRIOL
    43353-034CalcitriolCalcitriol
    68071-4487CalcitriolCalcitriol
    68151-0088CALCITRIOLCALCITRIOL
    69452-207CalcitriolCalcitriol
    69452-208CalcitriolCalcitriol
    71335-0901CalcitriolCalcitriol
    71335-0443CalcitriolCalcitriol
    43353-138CALCITRIOLCALCITRIOL
    43353-998CalcitriolCalcitriol
    45802-608calcitriolcalcitriol
    51407-169CalcitriolCalcitriol
    51407-170CalcitriolCalcitriol
    60687-345CalcitriolCalcitriol
    63304-239CALCITRIOLCALCITRIOL
    63304-240CALCITRIOLCALCITRIOL
    63304-241CALCITRIOLCALCITRIOL
    64380-723CalcitriolCalcitriol
    64380-724CalcitriolCalcitriol
    64980-447CalcitriolCalcitriol
    65162-519CalcitriolCalcitriol
    65162-576CalcitriolCalcitriol
    66336-851CALCITRIOLCALCITRIOL
    62756-967CalcitriolCalcitriol
    62756-968CalcitriolCalcitriol
    68083-316CalcitriolCalcitriol
    30698-143Rocaltrolcalcitriol
    30698-144Rocaltrolcalcitriol
    30698-911Rocaltrolcalcitriol
    0299-2012Vecticalcalcitriol
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