NDC 17856-0527

METHADOSE

Methadone Hydrochloride

METHADOSE is a Oral Concentrate in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Methadone Hydrochloride.

Product ID17856-0527_197fb88c-2353-4941-984f-fb9384b4b974
NDC17856-0527
Product TypeHuman Prescription Drug
Proprietary NameMETHADOSE
Generic NameMethadone Hydrochloride
Dosage FormConcentrate
Route of AdministrationORAL
Marketing Start Date2010-03-10
Marketing CategoryNDA / NDA
Application NumberNDA017116
Labeler NameAtlantic Biologicals Corps
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0527-1

.5 mL in 1 SYRINGE (17856-0527-1)
Marketing Start Date2021-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0527-1 [17856052701]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-24

NDC 17856-0527-2 [17856052702]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-24

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:4c796a39-d87f-4358-9d4b-26e27464b642
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991147
  • 991149

    • Pharmacological Class

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

    NDC Crossover Matching brand name "METHADOSE" or generic name "Methadone Hydrochloride"

    NDCBrand NameGeneric Name
    17856-0527METHADOSEMETHADOSE
    0406-0527METHADOSEMETHADOSE
    17856-0526METHADOSEMETHADOSE
    0054-4538DISKETSMethadone Hydrochloride
    0054-4218DOLOPHINEMETHADONE HYDROCHLORIDE
    0054-4219DOLOPHINEMETHADONE HYDROCHLORIDE
    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

    Trademark Results [METHADOSE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    METHADOSE
    METHADOSE
    72409510 0958455 Live/Registered
    MALLINCKRODT CHEMICAL WORKS
    1971-12-06
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