NDC 53217-261

Naltrexone Hydrochloride

Naltrexone Hydrochloride

Naltrexone Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Naltrexone Hydrochloride.

Product ID53217-261_9f0d222c-f87f-486b-b186-b09b1173fc9b
NDC53217-261
Product TypeHuman Prescription Drug
Proprietary NameNaltrexone Hydrochloride
Generic NameNaltrexone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA075274
Labeler NameAidarex Pharmaceuticals LLC
Substance NameNALTREXONE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-261-30

30 TABLET, FILM COATED in 1 BOTTLE (53217-261-30)
Marketing Start Date2013-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-261-30 [53217026130]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075274
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:f58d9be1-a428-45df-9c0b-369e93e71c6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483744
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Naltrexone Hydrochloride" or generic name "Naltrexone Hydrochloride"

    NDCBrand NameGeneric Name
    0406-1170NALTREXONE HYDROCHLORIDEnaltrexone hydrochloride
    0904-7036NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE
    16729-081Naltrexone HydrochlorideNaltrexone Hydrochloride
    42291-632Naltrexone HydrochlorideNaltrexone Hydrochloride
    47335-326NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE
    50090-2866Naltrexone HydrochlorideNaltrexone Hydrochloride
    50090-3076Naltrexone HydrochlorideNaltrexone Hydrochloride
    50090-3929NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE
    50090-4925Naltrexone HydrochlorideNaltrexone Hydrochloride
    50090-4926Naltrexone HydrochlorideNaltrexone Hydrochloride
    51224-206Naltrexone HydrochlorideNaltrexone Hydrochloride
    53217-261Naltrexone HydrochlorideNaltrexone Hydrochloride
    62135-242Naltrexone HydrochlorideNaltrexone Hydrochloride
    63629-1046Naltrexone HydrochlorideNaltrexone Hydrochloride
    63629-1047Naltrexone HydrochlorideNaltrexone Hydrochloride
    68071-2156Naltrexone HydrochlorideNaltrexone Hydrochloride
    68071-2721Naltrexone HydrochlorideNaltrexone Hydrochloride
    68084-291NALTREXONE HYDROCHLORIDEnaltrexone hydrochloride
    68094-853Naltrexone Hydrochloridenaltrexone Hydrochloride
    68788-7084Naltrexone HydrochlorideNaltrexone Hydrochloride
    70518-1146Naltrexone HydrochlorideNaltrexone Hydrochloride
    70518-1312NALTREXONE HYDROCHLORIDEnaltrexone hydrochloride
    70518-2718NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE
    71335-0014Naltrexone HydrochlorideNaltrexone Hydrochloride
    76519-1160NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE
    71335-1480NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE

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