NDC 0406-0540

METHADOSE DISPERSIBLE

Methadone Hydrochloride

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

Product ID0406-0540_4322be8b-c7bf-4773-a1af-ed408b24172f
NDC0406-0540
Product TypeHuman Prescription Drug
Proprietary NameMETHADOSE DISPERSIBLE
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1993-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA074184
Labeler NameSpecGx LLC
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0406-0540-34

100 TABLET in 1 BOTTLE (0406-0540-34)
Marketing Start Date1993-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-0540-34 [00406054034]

METHADOSE DISPERSIBLE TABLET
Marketing CategoryANDA
Application NumberANDA074184
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-04-29

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:544483e6-6f9d-4371-9e93-313e54e0ea05
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864978
  • 864980
  • UPC Code
  • 0304062540017
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    60687-209METHADOSE DISPERSIBLEMETHADOSE DISPERSIBLE
    0406-0540METHADOSE DISPERSIBLEMETHADOSE DISPERSIBLE
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.