NDC 47335-326

NALTREXONE HYDROCHLORIDE

Naltrexone Hydrochloride

NALTREXONE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Naltrexone Hydrochloride.

Product ID47335-326_8bd401f3-7879-472c-9a54-8ac386ad5f7f
NDC47335-326
Product TypeHuman Prescription Drug
Proprietary NameNALTREXONE HYDROCHLORIDE
Generic NameNaltrexone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-29
Marketing CategoryANDA / ANDA
Application NumberANDA090356
Labeler NameSun Pharmaceutical Industries, 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 47335-326-08

100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-326-18 [47335032618]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

NDC 47335-326-08 [47335032608]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29

NDC 47335-326-83 [47335032683]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29

NDC 47335-326-88 [47335032688]

NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29

Drug Details

Active Ingredients

IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:0f30f885-d0cd-4fa6-a8e0-142f08a56792
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483744
    • UPC Code
  • 0347335326833

    • Pharmacological Class

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

    Medicade Reported Pricing

    47335032688 NALTREXONE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    47335032683 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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