NDC 35356-835

METHADONE HYDROCHLORIDE

Methadone Hydrochloride

METHADONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Methadone Hydrochloride.

Product ID35356-835_63b10cdd-c9e4-4fe5-a2c9-b9f26735bc96
NDC35356-835
Product TypeHuman Prescription Drug
Proprietary NameMETHADONE HYDROCHLORIDE
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-01-01
Marketing End Date2023-03-31
Marketing CategoryNDA / NDA
Application NumberNDA006134
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 35356-835-30

30 TABLET in 1 BOTTLE, PLASTIC (35356-835-30)
Marketing Start Date2008-01-01
Marketing End Date2023-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-835-30 [35356083530]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryNDA
Application NumberNDA006134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-01

NDC 35356-835-60 [35356083560]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryNDA
Application NumberNDA006134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-01

NDC 35356-835-90 [35356083590]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryNDA
Application NumberNDA006134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-01
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:db37a292-5685-4f10-92fc-57631e1a25f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864718
  • 864706
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "METHADONE HYDROCHLORIDE" or generic name "Methadone Hydrochloride"

    NDCBrand NameGeneric Name
    0054-0391Methadone HydrochlorideMethadone Hydrochloride
    0054-0392Methadone HydrochlorideMethadone Hydrochloride
    0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-0710METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-3553Methadone HydrochlorideMethadone Hydrochloride
    0054-3555Methadone HydrochlorideMethadone Hydrochloride
    0054-3556Methadone HydrochlorideMethadone Hydrochloride
    0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    67877-116Methadone HydrochlorideMethadone Hydrochloride
    68084-738METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    68462-801Methadone HydrochlorideMethadone Hydrochloride
    68462-800Methadone HydrochlorideMethadone Hydrochloride
    0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    70166-284Methadone HydrochlorideMethadone Hydrochloride
    71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    71335-0735Methadone HydrochlorideMethadone Hydrochloride
    71335-0493Methadone HydrochlorideMethadone Hydrochloride
    0904-6530Methadone HydrochlorideMethadone Hydrochloride
    13107-088Methadone HydrochlorideMethadone Hydrochloride
    13107-089Methadone HydrochlorideMethadone Hydrochloride
    17856-3553Methadone HydrochlorideMethadone Hydrochloride
    17856-3554Methadone HydrochlorideMethadone Hydrochloride
    17478-380Methadone HydrochlorideMethadone Hydrochloride
    17856-3556Methadone HydrochlorideMethadone Hydrochloride
    17856-3555Methadone HydrochlorideMethadone Hydrochloride
    35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    42806-318Methadone HydrochlorideMethadone Hydrochloride
    42806-317Methadone HydrochlorideMethadone Hydrochloride
    52959-386METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    52959-435METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    57664-603Methadone hydrochlorideMethadone hydrochloride
    57664-602Methadone hydrochlorideMethadone hydrochloride
    60687-214Methadone HydrochlorideMethadone Hydrochloride
    61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    63739-006Methadone HydrochlorideMethadone Hydrochloride
    0406-1510Methadone HydrochlorideMethadone Hydrochloride
    0406-2540METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5755METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5771METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    66689-695Methadone HydrochlorideMethadone Hydrochloride
    66689-694Methadone HydrochlorideMethadone Hydrochloride
    66689-711Methadone HydrochlorideMethadone Hydrochloride
    66689-712Methadone HydrochlorideMethadone Hydrochloride
    66689-810Methadone HydrochlorideMethadone Hydrochloride
    66689-820Methadone HydrochlorideMethadone Hydrochloride
    66689-898Methadone HydrochlorideMethadone Hydrochloride
    67457-217Methadone HydrochlorideMethadone Hydrochloride

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