NDC 52584-978

NALOXONE HYDROCHLORIDE

Naloxone Hydrochloride

NALOXONE HYDROCHLORIDE is a Parenteral Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Naloxone Hydrochloride.

Product ID52584-978_29061dc9-9031-47a8-8518-4d4b69b53ac6
NDC52584-978
Product TypeHuman Prescription Drug
Proprietary NameNALOXONE HYDROCHLORIDE
Generic NameNaloxone Hydrochloride
Dosage FormInjection
Route of AdministrationPARENTERAL
Marketing Start Date2013-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA072076
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52584-978-01

1 BOX in 1 BAG (52584-978-01) > 1 SYRINGE in 1 BOX > 2 mL in 1 SYRINGE
Marketing Start Date2013-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-978-01 [52584097801]

NALOXONE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA072076
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-06

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:3dc4b694-f994-4e94-9f90-ea5281127935
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191250
  • 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
    0641-6260Naloxone HydrochlorideNalxone Hydrochloride
    0781-7176Naloxone HydrochlorideNaloxone Hydrochloride Nasal Spray
    17478-041Naloxone HydrochlorideNaloxone Hydrochloride
    17478-042Naloxone HydrochlorideNaloxone Hydrochloride
    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
    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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