NDC 70069-071

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 Somerset Therapeutics, Llc. The primary component is Naloxone Hydrochloride.

Product ID70069-071_061722cc-575a-4200-83a0-011af7d6d463
NDC70069-071
Product TypeHuman Prescription Drug
Proprietary NameNaloxone Hydrochloride
Generic NameNaloxone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2017-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA207633
Labeler NameSomerset Therapeutics, LLC
Substance NameNALOXONE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70069-071-10

10 VIAL in 1 CARTON (70069-071-10) > 1 mL in 1 VIAL (70069-071-01)
Marketing Start Date2017-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-071-10 [70069007110]

Naloxone Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207633
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-08

NDC 70069-071-01 [70069007101]

Naloxone Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207633
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-08

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE.4 mg/mL

OpenFDA Data

SPL SET ID:dfa48492-d83b-48cc-9ad1-bdc0c2ac9931
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659929
  • UPC Code
  • 0370069071014
  • 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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