NDC 55150-209

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Dexmedetomidine Hydrochloride.

Product ID55150-209_18724588-5172-47e8-8f4d-c55ebde50771
NDC55150-209
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine
Generic NameDexmedetomidine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA205867
Labeler NameAuroMedics Pharma LLC
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 Through2021-12-31

Packaging

NDC 55150-209-02

25 VIAL in 1 CARTON (55150-209-02) > 2 mL in 1 VIAL
Marketing Start Date2016-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-209-02 [55150020902]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205867
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-17

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

OpenFDA Data

SPL SET ID:8c162541-986b-4b30-866c-b2631ba2c975
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309710
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    16729-239DexmedetomidineDexmedetomidine
    16729-432DEXMEDETOMIDINEDEXMEDETOMIDINE
    17478-055DexmedetomidineDexmedetomidine Hydrochloride
    55150-209DexmedetomidineDexmedetomidine
    57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINE
    66794-230DexmedetomidineDexmedetomidine
    66794-233DexmedetomidineDexmedetomidine
    66794-238DexmedetomidineDexmedetomidine
    67457-251Dexmedetomidinedexmedetomidine
    70860-605Dexmedetomidinedexmedetomidine
    71288-505DEXMEDETOMIDINEDEXMEDETOMIDINE
    71872-7150Dexmedetomidinedexmedetomidine
    81092-1120IGALMIDEXMEDETOMIDINE
    81092-1180IGALMIDEXMEDETOMIDINE

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