NDC 16729-081

Naltrexone Hydrochloride

Naltrexone Hydrochloride

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

Product ID16729-081_4809b267-b0d6-4588-e054-00144ff88e88
NDC16729-081
Product TypeHuman Prescription Drug
Proprietary NameNaltrexone Hydrochloride
Generic NameNaltrexone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA091205
Labeler NameAccord Healthcare, Inc.
Substance NameNALTREXONE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-081-01

100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)
Marketing Start Date2012-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-081-10 [16729008110]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-18

NDC 16729-081-01 [16729008101]

Naltrexone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091205
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-18

Drug Details

Active Ingredients

IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:49aa3d6d-2270-4615-aafa-b440859ab870
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483744
  • Pharmacological Class

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

    Medicade Reported Pricing

    16729008110 NALTREXONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    16729008101 NALTREXONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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