NDC 43353-633

Rocaltrol

Calcitriol

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

Product ID43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a
NDC43353-633
Product TypeHuman Prescription Drug
Proprietary NameRocaltrol
Generic NameCalcitriol
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2009-08-10
Marketing CategoryNDA / NDA
Application NumberNDA018044
Labeler NameAphena Pharma Solutions - Tennessee, Inc.
Substance NameCALCITRIOL
Active Ingredient Strength0 ug/1
Pharm ClassesCholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-633-81

800 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-633-81)
Marketing Start Date2009-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-633-81 [43353063381]

Rocaltrol CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA018044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CALCITRIOL.25 ug/1

OpenFDA Data

SPL SET ID:1b2aa7df-0f38-460e-b1f1-d7473be4ab3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 209006
  • 308867

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    30698-143Rocaltrolcalcitriol
    30698-144Rocaltrolcalcitriol
    30698-911Rocaltrolcalcitriol
    43353-633RocaltrolRocaltrol
    0054-0007CalcitriolCalcitriol
    0054-3120CalcitriolCalcitriol
    0093-7352CalcitriolCalcitriol
    0093-7353CalcitriolCalcitriol
    0143-9728CalcitriolCalcitriol
    0179-0245CalcitriolCalcitriol
    17478-831CalcitriolCalcitriol
    17478-931CalcitriolCalcitriol
    17478-932CalcitriolCalcitriol
    17856-3120CalcitriolCalcitriol
    23155-118CalcitriolCalcitriol
    23155-119CalcitriolCalcitriol
    23155-662CALCITRIOLCALCITRIOL
    23155-663CALCITRIOLCALCITRIOL
    43353-034CalcitriolCalcitriol
    0299-2012Vecticalcalcitriol

    Trademark Results [Rocaltrol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROCALTROL
    ROCALTROL
    73126177 1082213 Live/Registered
    HOFFMANN-LA ROCHE INC.
    1977-05-11
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