NDC 52584-058

NALOXONE HYDROCHLORIDE

Naloxone Hydrochloride

NALOXONE HYDROCHLORIDE is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Naloxone Hydrochloride.

Product ID52584-058_4aff02a2-4ff8-4a21-9f05-6ceda855ff93
NDC52584-058
Product TypeHuman Prescription Drug
Proprietary NameNALOXONE HYDROCHLORIDE
Generic NameNaloxone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA208871
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-058-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-058-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-06-12
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-058-01 [52584005801]

NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208871
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-12
Marketing End Date2021-04-30

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE.4 mg/mL

OpenFDA Data

SPL SET ID:ccecb486-6397-4517-ae1a-3ab00cf1a4d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659929
  • Pharmacological Class

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

    NDC Crossover Matching brand name "NALOXONE HYDROCHLORIDE" or generic name "Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    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
    0641-6132Naloxone HydrochlorideNalxone Hydrochloride
    0641-6205Naloxone HydrochlorideNaloxone Hydrochloride
    0641-6260Naloxone HydrochlorideNalxone Hydrochloride
    0781-7176Naloxone HydrochlorideNaloxone Hydrochloride Nasal Spray
    70069-071Naloxone HydrochlorideNaloxone Hydrochloride
    70069-072Naloxone HydrochlorideNaloxone Hydrochloride
    70385-2013Naloxone HydrochlorideNaloxone Hydrochloride
    71872-7018Naloxone HydrochlorideNaloxone Hydrochloride
    76329-3469Naloxone HydrochlorideNaloxone Hydrochloride
    76329-3369Naloxone HydrochlorideNaloxone Hydrochloride
    76329-1469Naloxone HydrochlorideNaloxone Hydrochloride
    17478-041Naloxone HydrochlorideNaloxone Hydrochloride
    17478-042Naloxone HydrochlorideNaloxone Hydrochloride
    50090-1836Naloxone HydrochlorideNaloxone Hydrochloride
    50090-3294Naloxone HydrochlorideNaloxone Hydrochloride
    50090-3154Naloxone HydrochlorideNaloxone Hydrochloride
    51662-1238NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    52584-469Naloxone HydrochlorideNaloxone Hydrochloride
    52584-058NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    52584-978NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    52584-782Naloxone HydrochlorideNaloxone Hydrochloride
    52584-369NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    52584-215Naloxone HydrochlorideNaloxone Hydrochloride
    55154-4732Naloxone HydrochlorideNaloxone Hydrochloride
    55154-3954Naloxone HydrochlorideNaloxone Hydrochloride
    55154-6980Naloxone HydrochlorideNaloxone Hydrochloride
    63739-463Naloxone HydrochlorideNaloxone Hydrochloride
    64725-1782Naloxone HydrochlorideNaloxone Hydrochloride
    67457-292Naloxone HydrochlorideNaloxone Hydrochloride
    67457-599Naloxone HydrochlorideNaloxone Hydrochloride
    67457-299Naloxone HydrochlorideNaloxone Hydrochloride
    71872-7009Naloxone HydrochlorideNaloxone Hydrochloride
    51662-1385NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    55150-328NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE
    55150-327Naloxone HydrochlorideNaloxone Hydrochloride

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