NDC 0406-0527

METHADOSE

Methadone Hydrochloride

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

Product ID0406-0527_33c670a2-0b68-423b-ba82-1d9704a709da
NDC0406-0527
Product TypeHuman Prescription Drug
Proprietary NameMETHADOSE
Generic NameMethadone Hydrochloride
Dosage FormConcentrate
Route of AdministrationORAL
Marketing Start Date1973-03-14
Marketing CategoryNDA / NDA
Application NumberNDA017116
Labeler NameSpecGx LLC
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0406-0527-10

1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)
Marketing Start Date1973-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-0527-10 [00406052710]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-03-14

NDC 0406-0527-15 [00406052715]

METHADOSE CONCENTRATE
Marketing CategoryNDA
Application NumberNDA017116
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1973-03-14

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:808a9d0b-720b-4034-a862-5122ff514608
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991147
  • 991149
    • UPC Code
  • 0304060527102
  • 0304068725104

    • 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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