NDC 17856-3555

Methadone Hydrochloride

Methadone Hydrochloride

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

Product ID17856-3555_bb65d8d4-bf3b-4072-8857-b7332578da14
NDC17856-3555
Product TypeHuman Prescription Drug
Proprietary NameMethadone Hydrochloride
Generic NameMethadone Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1981-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA087393
Labeler NameAtlantic Biologicals Corps
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 17856-3555-1

2 mL in 1 CUP (17856-3555-1)
Marketing Start Date2020-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-3555-2 [17856355502]

Methadone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA087393
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-27
Inactivation Date2020-01-31
Reactivation Date2020-04-28

NDC 17856-3555-5 [17856355505]

Methadone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA087393
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-27
Inactivation Date2020-01-31
Reactivation Date2020-04-28

NDC 17856-3555-4 [17856355504]

Methadone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA087393
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-27

NDC 17856-3555-1 [17856355501]

Methadone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA087393
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-27
Inactivation Date2020-01-31
Reactivation Date2020-04-28

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864769
  • 864761
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67877-116Methadone HydrochlorideMethadone Hydrochloride
    68084-738METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    68462-801Methadone HydrochlorideMethadone Hydrochloride
    68462-800Methadone HydrochlorideMethadone Hydrochloride
    0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    70166-284Methadone HydrochlorideMethadone Hydrochloride
    71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    71335-0735Methadone HydrochlorideMethadone Hydrochloride
    71335-0493Methadone HydrochlorideMethadone Hydrochloride
    0904-6530Methadone HydrochlorideMethadone Hydrochloride
    13107-088Methadone HydrochlorideMethadone Hydrochloride
    13107-089Methadone HydrochlorideMethadone Hydrochloride
    17856-3553Methadone HydrochlorideMethadone Hydrochloride
    17856-3554Methadone HydrochlorideMethadone Hydrochloride
    17478-380Methadone HydrochlorideMethadone Hydrochloride
    17856-3556Methadone HydrochlorideMethadone Hydrochloride
    17856-3555Methadone HydrochlorideMethadone Hydrochloride
    35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    42806-318Methadone HydrochlorideMethadone Hydrochloride
    42806-317Methadone HydrochlorideMethadone Hydrochloride
    52959-386METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    52959-435METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    57664-603Methadone hydrochlorideMethadone hydrochloride
    57664-602Methadone hydrochlorideMethadone hydrochloride
    60687-214Methadone HydrochlorideMethadone Hydrochloride
    61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    63739-006Methadone HydrochlorideMethadone Hydrochloride
    0406-1510Methadone HydrochlorideMethadone Hydrochloride
    0406-2540METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5755METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5771METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    66689-695Methadone HydrochlorideMethadone Hydrochloride
    66689-694Methadone HydrochlorideMethadone Hydrochloride
    66689-711Methadone HydrochlorideMethadone Hydrochloride
    66689-712Methadone HydrochlorideMethadone Hydrochloride
    66689-810Methadone HydrochlorideMethadone Hydrochloride
    66689-820Methadone HydrochlorideMethadone Hydrochloride
    66689-898Methadone HydrochlorideMethadone Hydrochloride
    67457-217Methadone HydrochlorideMethadone Hydrochloride

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