NDC 52584-638

PRECEDEX

Dexmedetomidine Hydrochloride

PRECEDEX is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Dexmedetomidine Hydrochloride.

Product ID52584-638_20d3732e-7b12-482d-abb7-24f0719d9a9f
NDC52584-638
Product TypeHuman Prescription Drug
Proprietary NamePRECEDEX
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-07-02
Marketing CategoryNDA / NDA
Application NumberNDA021038
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength100 ug/mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-638-02

1 VIAL in 1 BAG (52584-638-02) > 2 mL in 1 VIAL
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-638-02 [52584063802]

PRECEDEX INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA021038
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-02

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

OpenFDA Data

SPL SET ID:30ee2937-bf84-4c14-bc37-6a6883eea264
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309710
  • 284397

    • Pharmacological Class

    • Adrenergic alpha2-Agonists [MoA]
    • Central alpha-2 Adrenergic Agonist [EPC]
    • General Anesthesia [PE]
    • Adrenergic alpha2-Agonists [MoA]
    • Central alpha-2 Adrenergic Agonist [EPC]
    • General Anesthesia [PE]

    NDC Crossover Matching brand name "PRECEDEX" or generic name "Dexmedetomidine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9938PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDE
    0409-0155PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1174PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1434PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1454PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1638PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1660PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    52584-638PRECEDEXPRECEDEX
    0143-9525Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    0143-9526Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE

    Trademark Results [PRECEDEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRECEDEX
    PRECEDEX
    75383541 2419482 Live/Registered
    Orion Corporation
    1997-11-03
    PRECEDEX
    PRECEDEX
    75197776 not registered Dead/Abandoned
    Orion Corporation
    1996-11-13
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