NDC 60842-051

Evzio

Naloxone Hydrochloride

Evzio is a Intramuscular; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Kaleo, Inc.. The primary component is Naloxone Hydrochloride.

Product ID60842-051_4176e25d-8589-42ca-b24c-c7f3149017fe
NDC60842-051
Product TypeHuman Prescription Drug
Proprietary NameEvzio
Generic NameNaloxone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; SUBCUTANEOUS
Marketing Start Date2016-10-19
Marketing CategoryNDA / NDA
Application NumberNDA209862
Labeler Namekaleo, Inc.
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength2 mg/.4mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60842-051-01

2 DOSE PACK in 1 CARTON (60842-051-01) > .4 mL in 1 DOSE PACK
Marketing Start Date2016-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60842-051-01 [60842005101]

Evzio INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-19

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE2 mg/.4mL

OpenFDA Data

SPL SET ID:5fbe8d17-a72f-406d-a736-48e61620f9d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1855732
  • 1855730
    • UPC Code
  • 0060842051011

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    60842-051EvzioEvzio
    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 [Evzio]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EVZIO
    EVZIO
    85939628 4641993 Live/Registered
    Intelliject, Inc.
    2013-05-22
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.