NDC 55700-457

NARCAN

Naloxone Hydrochloride

NARCAN is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Naloxone Hydrochloride.

Product ID55700-457_06719fe0-2433-48aa-b92f-8e7a5c867541
NDC55700-457
Product TypeHuman Prescription Drug
Proprietary NameNARCAN
Generic NameNaloxone Hydrochloride
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2015-11-18
Marketing CategoryNDA / NDA
Application NumberNDA208411
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength4 mg/.1mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55700-457-01

2 VIAL, SINGLE-DOSE in 1 PACKAGE (55700-457-01) > .1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-457-01 [55700045701]

NARCAN SPRAY
Marketing CategoryNDA
Application NumberNDA208411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE4 mg/.1mL

OpenFDA Data

SPL SET ID:7db1a202-c9b3-4c6b-a808-ff24f31fd6bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1725059
  • 1725064

    • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]
    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "NARCAN" or generic name "Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    69547-353NarcanNarcan
    69547-212NarcanNarcan
    50090-2422NarcanNarcan
    55700-457NARCANNARCAN
    71205-528NarcanNarcan
    0093-2165Naloxone HydrochlorideNaloxone Hydrochloride
    0404-9920Naloxone HydrochlorideNaloxone Hydrochloride
    0404-9921NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0404-9923NALOXONE HYDROCHLORIDEnaloxone hydrochloride
    0409-1215Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0409-1219Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0409-1782Naloxone HydrochlorideNALOXONE HYDROCHLORIDE
    0641-6205Naloxone HydrochlorideNaloxone Hydrochloride
    17478-041Naloxone HydrochlorideNaloxone Hydrochloride

    Trademark Results [NARCAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NARCAN
    NARCAN
    88863752 not registered Live/Pending
    Adapt Pharma Operations Limited
    2020-04-08
    NARCAN
    NARCAN
    88863747 not registered Live/Pending
    Adapt Pharma Operations Limited
    2020-04-08
    NARCAN
    NARCAN
    87130416 5160883 Live/Registered
    Adapt Pharma Operations Limited
    2016-08-08
    NARCAN
    NARCAN
    86364205 not registered Dead/Abandoned
    Endo Pharmaceuticals Inc.
    2014-08-12
    NARCAN
    NARCAN
    72225014 0808366 Live/Registered
    ENDO LABORATORIES INC.
    1965-08-05
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