NDC 57884-3091

DEXMEDETOMIDINE HYDROCHLORIDE

Dexmedetomidine Hydrochloride

DEXMEDETOMIDINE HYDROCHLORIDE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Jiangsu Hengrui Medicine Co., Ltd.. The primary component is Dexmedetomidine Hydrochloride.

Product ID57884-3091_77d13f0a-65c0-9673-e053-2a91aa0a2d4b
NDC57884-3091
Product TypeHuman Prescription Drug
Proprietary NameDEXMEDETOMIDINE HYDROCHLORIDE
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA209065
Labeler NameJiangsu Hengrui Medicine Co., Ltd.
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 57884-3091-3

10 VIAL in 1 CARTON (57884-3091-3) > 2 mL in 1 VIAL
Marketing Start Date2017-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57884-3091-1 [57884309101]

DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19
Marketing End Date2017-10-10

NDC 57884-3091-3 [57884309103]

DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

NDC 57884-3091-2 [57884309102]

DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209065
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-19

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

OpenFDA Data

SPL SET ID:6f6c592a-6c87-461c-929f-77cba42029c8
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 HYDROCHLORIDE" or generic name "Dexmedetomidine Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9525Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    0143-9526Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    68382-124DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    70771-1319DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    71872-7122Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    0781-3297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    16729-239Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
    16729-432Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
    42023-146Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    44567-601Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    44567-603Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    45963-906Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    44567-600Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    44567-602Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    55150-209Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    57664-596Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    57884-3091DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    63323-421Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    67457-251Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    63323-671Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    71225-126DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    71872-7030Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
    71872-7031Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    67457-925DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    67457-924DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    43598-975DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    70121-1388Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    70121-1389Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    68083-238Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
    43598-976DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
    0404-9938PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDE
    0409-0155PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1174PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1434PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1454PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1638PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
    0409-1660PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
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