NDC 0054-3120

Calcitriol

Calcitriol

Calcitriol is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Calcitriol.

Product ID0054-3120_6596f0ea-7fe9-4de5-8370-88c980461c7c
NDC0054-3120
Product TypeHuman Prescription Drug
Proprietary NameCalcitriol
Generic NameCalcitriol
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2003-07-18
Marketing CategoryANDA / ANDA
Application NumberANDA076242
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameCALCITRIOL
Active Ingredient Strength1 ug/mL
Pharm ClassesCholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0054-3120-41

1 BOTTLE, WITH APPLICATOR in 1 CARTON (0054-3120-41) > 15 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2003-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-3120-41 [00054312041]

Calcitriol SOLUTION
Marketing CategoryANDA
Application NumberANDA076242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-07-18

Drug Details

Active Ingredients

IngredientStrength
CALCITRIOL1 ug/mL

OpenFDA Data

SPL SET ID:3289b482-8733-484d-b1db-d7f4cdcd1ac2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313932
  • 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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