NDC 0054-3553

Methadone Hydrochloride

Methadone Hydrochloride

Methadone Hydrochloride is a Oral Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Methadone Hydrochloride.

Product ID0054-3553_cd9c33e5-076b-4be7-88e5-add57f36c8f7
NDC0054-3553
Product TypeHuman Prescription Drug
Proprietary NameMethadone Hydrochloride
Generic NameMethadone Hydrochloride
Dosage FormConcentrate
Route of AdministrationORAL
Marketing Start Date1988-09-06
Marketing CategoryANDA / ANDA
Application NumberANDA089897
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-3553-44

30 mL in 1 BOTTLE, DROPPER (0054-3553-44)
Marketing Start Date1988-09-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-3553-44 [00054355344]

Methadone Hydrochloride CONCENTRATE
Marketing CategoryANDA
Application NumberANDA089897
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1988-09-06

NDC 0054-3553-67 [00054355367]

Methadone Hydrochloride CONCENTRATE
Marketing CategoryANDA
Application NumberANDA088897
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1988-09-06
Marketing End Date2012-08-06

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:d0e6a966-179a-45e0-8444-4c1b8523f8d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991147
  • Pharmacological Class

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