NDC 0054-4538

DISKETS

Methadone Hydrochloride

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

Product ID0054-4538_386b93c4-430f-4f11-82e1-6731755fb114
NDC0054-4538
Product TypeHuman Prescription Drug
Proprietary NameDISKETS
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1973-03-14
Marketing CategoryNDA / NDA
Application NumberNDA017058
Labeler NameHikma Pharmaceuticals USA Inc.
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 0054-4538-25

100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)
Marketing Start Date1973-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-4538-25 [00054453825]

DISKETS TABLET
Marketing CategoryNDA
Application NumberNDA017058
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1973-03-14

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:e6af84de-cbfc-4a3b-bd73-6bcf77337168
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864978
  • 1990745
  • UPC Code
  • 0300544538251
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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 [DISKETS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DISKETS
    DISKETS
    78077626 2713511 Live/Registered
    ROXANE LABORATORIES, INC.
    2001-08-06
    DISKETS
    DISKETS
    73224880 1149576 Dead/Expired
    Eli Lilly and Company
    1979-07-25
    DISKETS
    DISKETS
    71692290 0621643 Dead/Expired
    ZUCKERMAN, MAX
    1955-08-01

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