NDC 52959-435

METHADONE HYDROCHLORIDE

Methadone Hydrochloride

METHADONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Methadone Hydrochloride.

Product ID52959-435_8a7832fd-a24f-43b5-b46c-6043dfb24114
NDC52959-435
Product TypeHuman Prescription Drug
Proprietary NameMETHADONE HYDROCHLORIDE
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-05-19
Marketing CategoryANDA / ANDA
Application NumberANDA040517
Labeler NameH.J. Harkins Company Inc.
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-435-60

60 TABLET in 1 BOTTLE (52959-435-60)
Marketing Start Date2009-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-435-30 [52959043530]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-19
Inactivation Date2019-11-13

NDC 52959-435-60 [52959043560]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-19
Inactivation Date2019-11-13

NDC 52959-435-02 [52959043502]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-19
Inactivation Date2019-11-13

NDC 52959-435-90 [52959043590]

METHADONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA040517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-19
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:3c926b78-999e-4d26-9498-7f1bcaf0b992
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

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