NDC 0409-1638

Precedex

Dexmedetomidine Hydrochloride

Precedex is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Dexmedetomidine Hydrochloride.

Product ID0409-1638_2846e0a6-76ab-4f5a-989f-105ea390809c
NDC0409-1638
Product TypeHuman Prescription Drug
Proprietary NamePrecedex
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2004-11-30
Marketing CategoryNDA / NDA
Application NumberNDA021038
Labeler NameHospira, 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 Through2019-12-31

Packaging

NDC 0409-1638-02

25 VIAL in 1 TRAY (0409-1638-02) > 2 mL in 1 VIAL (0409-1638-32)
Marketing Start Date2004-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1638-02 [00409163802]

Precedex INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA021038
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-30

NDC 0409-1638-32 [00409163832]

Precedex INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA021038
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-18

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

OpenFDA Data

SPL SET ID:548a88c0-afda-427e-75ac-5af0cfa2224c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1718910
  • 309710
  • 1718902
  • 1718900
  • 1718907
  • 1718906
  • 284397
  • 1718909

    • Pharmacological Class

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.