NDC 30698-911

Rocaltrol

Calcitriol

Rocaltrol is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Validus Pharmaceuticals Llc. The primary component is Calcitriol.

Product ID30698-911_73cbee56-369c-478d-84e8-df500e69dc82
NDC30698-911
Product TypeHuman Prescription Drug
Proprietary NameRocaltrol
Generic NameCalcitriol
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2009-07-23
Marketing CategoryNDA / NDA
Application NumberNDA021068
Labeler NameValidus Pharmaceuticals LLC
Substance NameCALCITRIOL
Active Ingredient Strength1 ug/mL
Pharm ClassesCholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 30698-911-15

15 mL in 1 BOTTLE (30698-911-15)
Marketing Start Date2009-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 30698-911-15 [30698091115]

Rocaltrol SOLUTION
Marketing CategoryNDA
Application NumberNDA021068
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-23

Drug Details

Active Ingredients

IngredientStrength
CALCITRIOL1 ug/mL

OpenFDA Data

SPL SET ID:d1013494-bf62-4e68-9f0c-e6571137f20f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261283
  • 313932
  • 308868
  • 209007
  • 209006
  • 308867
    • UPC Code
  • 0330698143018
  • 0330698143230
  • 0330698144015

    • Pharmacological Class

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