NDC 63323-421

Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

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

Product ID63323-421_19087b96-58fb-400b-b5c6-689e5e33c5c8
NDC63323-421
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine Hydrochloride
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA201072
Labeler NameFresenius Kabi USA, 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 Through2023-12-31

Packaging

NDC 63323-421-02

25 VIAL in 1 TRAY (63323-421-02) > 2 mL in 1 VIAL (63323-421-01)
Marketing Start Date2015-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-421-02 [63323042102]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201072
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-18

NDC 63323-421-16 [63323042116]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201072
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-18
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

OpenFDA Data

SPL SET ID:c1b8eb58-596b-481d-beb6-ba9d2237abf4
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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