NDC 58468-0127

Hectorol

Doxercalciferol

Hectorol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Doxercalciferol.

Product ID58468-0127_6eb95fe3-4632-40f2-9567-5c7790c0a537
NDC58468-0127
Product TypeHuman Prescription Drug
Proprietary NameHectorol
Generic NameDoxercalciferol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-12-08
Marketing CategoryNDA / NDA
Application NumberNDA021027
Labeler NameGenzyme Corporation
Substance NameDOXERCALCIFEROL
Active Ingredient Strength4 ug/2mL
Pharm ClassesErgocalciferols [CS],Vitamin D2 Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58468-0127-1

50 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) > 2 mL in 1 VIAL, MULTI-DOSE (58468-0127-0)
Marketing Start Date2008-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-0127-1 [58468012701]

Hectorol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-12-08

Drug Details

Active Ingredients

IngredientStrength
DOXERCALCIFEROL4 ug/2mL

OpenFDA Data

SPL SET ID:7efc3d9c-12f5-43f6-9a22-88d66cbe6f62
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 282609
  • 284411
  • 1790210
  • 1790208
  • 1790219
  • 1790220
  • Pharmacological Class

    • Ergocalciferols [CS]
    • Vitamin D2 Analog [EPC]
    • Ergocalciferols [CS]
    • Vitamin D2 Analog [EPC]

    NDC Crossover Matching brand name "Hectorol" or generic name "Doxercalciferol"

    NDCBrand NameGeneric Name
    58468-0123HectorolHectorol
    58468-0126HectorolHectorol
    58468-0127HectorolHectorol
    0054-0338DoxercalciferolDoxercalciferol
    0054-0339DoxercalciferolDoxercalciferol
    0054-0388DoxercalciferolDoxercalciferol
    0409-1330DOXERCALCIFEROLDOXERCALCIFEROL
    0641-6154DoxercalciferolDoxercalciferol
    0781-3305DoxercalciferolDoxercalciferol
    0955-1720DoxercalciferolDoxercalciferol
    0955-1721DoxercalciferolDoxercalciferol
    0955-1722DoxercalciferolDoxercalciferol
    17478-987DoxercalciferolDoxercalciferol
    17478-988DoxercalciferolDoxercalciferol
    23155-538DoxercalciferolDoxercalciferol
    23155-539DoxercalciferolDoxercalciferol

    Trademark Results [Hectorol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HECTOROL
    HECTOROL
    75312731 2336493 Live/Registered
    GENZYME CORPORATION
    1997-06-23

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