NDC 68788-7084

Naltrexone Hydrochloride

Naltrexone Hydrochloride

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

Product ID68788-7084_06982019-25a2-4bea-9e20-6c42b37c803e
NDC68788-7084
Product TypeHuman Prescription Drug
Proprietary NameNaltrexone Hydrochloride
Generic NameNaltrexone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-01-25
Marketing CategoryANDA / ANDA
Application NumberANDA091205
Labeler NamePreferred Pharmaceuticals Inc.
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 68788-7084-3

30 TABLET, FILM COATED in 1 BOTTLE (68788-7084-3)
Marketing Start Date2018-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7084-1 [68788708401]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Inactivation Date2020-01-31

NDC 68788-7084-3 [68788708403]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Inactivation Date2020-01-31

NDC 68788-7084-2 [68788708402]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Inactivation Date2020-01-31

NDC 68788-7084-6 [68788708406]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Inactivation Date2020-01-31

NDC 68788-7084-9 [68788708409]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:06982019-25a2-4bea-9e20-6c42b37c803e
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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