NDC 70385-2013

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 Sina Health Inc. The primary component is Naloxone Hydrochloride.

Product ID70385-2013_8117ec68-5782-e83b-e053-2a91aa0a9bf2
NDC70385-2013
Product TypeHuman Prescription Drug
Proprietary NameNaloxone Hydrochloride
Generic NameNaloxone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1987-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA070256
Labeler NameSina Health 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 70385-2013-1

10 VIAL, SINGLE-DOSE in 1 BAG (70385-2013-1) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70385-2013-1 [70385201301]

Naloxone Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA070256
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-03

Drug Details

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE.4 mg/mL

OpenFDA Data

SPL SET ID:2d53f70f-3c6d-6934-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659929
  • Pharmacological Class

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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.