NDC 0054-4218

DOLOPHINE

Methadone Hydrochloride

DOLOPHINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Methadone Hydrochloride.

Product ID0054-4218_01ec2d24-7a9d-45fa-88e7-94c48cd6c896
NDC0054-4218
Product TypeHuman Prescription Drug
Proprietary NameDOLOPHINE
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1947-08-13
Marketing CategoryNDA / NDA
Application NumberNDA006134
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0054-4218-25

100 TABLET in 1 BOTTLE, PLASTIC (0054-4218-25)
Marketing Start Date1947-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-4218-25 [00054421825]

DOLOPHINE TABLET
Marketing CategoryNDA
Application NumberNDA006134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1947-08-13

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:7a4840d6-98e3-4523-81a0-ef0b3a47d0c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864720
  • 864708
  • 864718
  • 864706
    • UPC Code
  • 0300544218252

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-4218DOLOPHINEMETHADONE HYDROCHLORIDE
    0054-4219DOLOPHINEMETHADONE HYDROCHLORIDE
    0054-4538DISKETSMethadone 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 [DOLOPHINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DOLOPHINE
    DOLOPHINE
    71538016 0506952 Live/Registered
    ELI LILLY AND COMPANY
    1947-10-16
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