NDC 17856-0526

METHADOSE

Methadone Hydrochloride

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

Product ID17856-0526_2c39cae3-ef02-463e-93be-c9f9c44bf257
NDC17856-0526
Product TypeHuman Prescription Drug
Proprietary NameMETHADOSE
Generic NameMethadone Hydrochloride
Dosage FormConcentrate
Route of AdministrationORAL
Marketing Start Date2019-05-14
Marketing CategoryNDA / NDA
Application NumberNDA017116
Labeler NameATLANTIC BIOLOGICALS CORP.
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 17856-0526-1

60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0526-1) > .5 mL in 1 SYRINGE
Marketing Start Date2021-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0526-2 [17856052602]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-14

NDC 17856-0526-1 [17856052601]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-14

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:db600aee-4d27-4df4-82b5-3034c335c240
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991147
  • 991149
  • Pharmacological Class

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